These positions (2 Vacancies) offer a fantastic opportunity to join a dedicated programming department. As a Graduate SAS Programmer, you will have the opportunity to gain foundation knowledge of SAS programming, developing good programming techniques for clinical trial reporting.
This is an office based role, you will be expected to spend the first year with 5 days a week in office to aid in training. You will be following a development plan designed to give you the knowledge you need to excel within the company. Following your first year it would be a hybrid model with 2-3 days in the office.
Quanticate has a Fast Track Program which works to identify your strengths and ascertain your interests, and then develop a personal training plan to help you to reach your career goals. You will experience rapid promotion through the Programming grades, enabling those capable to become leads on multiple clinical projects at a more junior level. Employees at Quanticate can progress through the three levels of Programming every 6 months, which means that within two years, you could become a Senior.
You will gain exposure to a broad range of clinical trial studies and real world evidence, working across Phases I-IV in a wide variety of therapeutic areas. Working as part of local and global project teams, you will have the opportunity to work on high profile, global studies for major pharmaceutical clients.
About the Company
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Objectives:
- Provide high quality statistical support to clients, which conforms to current Quanticate and client-specific standard operating procedures (SOPs) and processes, and to applicable regulatory requirements.
- Act as a lead point of contact with clients and accountable for enhancing customer satisfaction Lead cross-function operational teams to ensure successful delivery of projects.
Procedures:
- Provide high quality statistical support to studies including design and analysis of studies, writing SAPs and selecting optimum statistical methods, statistical sections of study protocols, estimates of sample size, and statistical general consultancy including study design and conduct.
- Work as operational lead, ensuring tasks are appropriately delegated to members of the project team in line with the requirements of the project plan. Lead cross-function operational teams to ensure successful delivery of projects.
- Monitor the work of the project team, and coordinate project delivery on time and within budget.
- Provide regulatory and submission support (PSUR, BB, DSMB, etc.)
Key Contacts/Relationships (Internal & External)
Internal
- Work closely with their line manager to review objectives, progress and development.
- Work closely with Senior and Principal Project Delivery Managers, Portfolio Managers/Director/VP, the Senior VP of Portfolio Delivery and Head of Programming and Statistics PMO allocated project teams, Senior Programming and Statistics staff, Group Managers, Clinicians and Medical Writers for the successful delivery of statistical activities.
- Work in Partnership with support functions including HR, Finance, IT and BD.
- Lead Statisticians, Senior Statisticians and Programmers assigned to projects to coordinate successful delivery of the required deliverables.
External
- Interact extensively with clients (including client PoC, statisticians, clinicians, medical writers, project managers) to lead the client relationship and successfully deliver statistical output, ensuring excellent customer care.
- Represent the company at external conferences and forums
Person Specification
Education:
- Qualified minimally to MSc level in Statistics or equivalent.
And/or:
- Have relevant experience within the pharmaceutical industry or medical sector.
- Understand the principles and procedures of statistics.
Skills:
- Strong statistical skills enabling independent provision of statistical advice and document review across a broad range of statistical applications.
- Good knowledge of SAS and experience with other statistical software.
- Proven ability to lead projects / Strong analytical and problem-solving skills.
- Significant experience in more than one study phase, with good understanding of all phases.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
For an informal chat please contact Andrew.Dixon@quanticate.com or connect with me via LinkedIn.
Senior Programmer - Home based or Hybrid
About the Company:
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Objectives:
- Technical expertise in support of project deliveries and training development of Programming personnel.
- Provide project and technical support, or line management support in the preparation and review of high-quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
Procedures:
Core
- Deliver excellent customer care in support of genuine value and a great customer experience.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Good knowledge of pharmaceutical industry standards
- Comprehensive understanding of current Quanticate, and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Provide mentoring in area of technical expertise.
- Ability to work with different, functions, and across sites, as required.
- Ability to review clinical documents, e.g. protocol, CRF and SAP.
- Demonstrated SAS programming knowledge to an advanced level with expected results in SAS competency test.
- Provide programming expertise and support within the function on programming standards, processes and procedures.
- Provide high quality deliverables and appropriate communication to the client within expected timelines and budget as directed by the Project Lead.
- Ability to represent the Company at external conferences, forums and working groups from a clinical programming perspective.
Key Contacts/Relationships (Internal & External)
Internal
- Has a close working relationship with Senior Programmers (all levels), Line Manager, HR and other functional staff.
- May deputise for a Senior Programmer II.
- Works closely with the project study teams (statisticians, clinicians, medical writers, project management) for the successful delivery of programming activities.
External
- Some interaction with clients to complete various programming activities. To fulfil this role, the Senior Programmer I may be required to be a key participant in project team meetings and be responsive on an ad hoc basis.
Person Specification
Education:
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Understanding of basic statistics.
Work Experience:
- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Preferably have programming experience covering activities from study set-up to final reporting.
Skills:
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
Principle Programmer
About the Company:
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Objectives:
- Multi-discipline role, with focus on delivering:
- Project leadership of assigned complex/multiple projects and/or
- Line management of assigned personnel and/or
- Technical oversight in support of Operations deliveries, projects, initiatives, and training development of Programming personnel.
- Lead process improvement and knowledge-sharing within the function.
- Provide advanced project and technical support in the preparation and review of high quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Input to the development of the Programming function and its staff, including encouraging and supporting commercial awareness.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
Procedures:
Core
- Deliver outstanding customer care in support of genuine value and a great customer experience.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Comprehensive knowledge of pharmaceutical industry standards.
- Comprehensive understanding of current Quanticate, and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Ensure adherence to all relevant SOPs, guidelines and processes.
- Maintain up-to-date knowledge of the external regulatory environment relating to programming, including ICH/GCP requirements, and provide advice and educate colleagues (and clients) on changes to regulatory requirements and/or other guidelines relating to programming.
- Provide high quality deliverables and appropriate communication within expected timelines and budget.
- Use acquired in-depth knowledge and broad expertise to create, update and enhance procedures and applicable SOPs within Programming.
- Identify, develop and lead cross-functional initiatives promoting knowledge-sharing within Quanticate.
- Provide mentoring and leadership, as required.
- Ability to perform Peer Review or Final Inspections, locally or globally, as required.
- Ability to critically review and provide comments on clinical documents, e.g. protocol, CRF and SAP.
- Ability to represent the Company at external conferences and forums.
- May become involved in industry initiatives and organisations (e.g. PhUSE Committees/Steering bodies).
- Participate in meetings such as recruitment, business development, finance and audits from a clinical programming perspective.
- Perform other reasonable tasks as requested by management.
- Assist with the implementation of and follow appropriate Project Management procedures.
- Input to the development of functional goals and objectives.
- Take responsibility for a functional objective.
- To be responsible and accountable for daily and accurate completion of timesheets.
- To ensure that all direct reports are actively encouraged and reminded of the need for daily and accurate completion of timesheets and to closely monitor the completion metrics.
Technical Ability
- SAS Programming knowledge and experience to enable oversight of programming teams.
- Provide programming advice internally and externally on complex clinical projects.
- Oversee the delivery of consistently high quality output in a timely manner.
- Ability to identify departmental technical training requirements.
- Oversee and/or develop/deliver SAS training and workshops and other related training sessions, as applicable.
- Encourage the acquirement of SAS, industry trends, other appropriate programming expertise and standards within Programming.
Project Management Ability
- Comprehensive knowledge of regulatory agency guidelines.
- Ability to plan resource requirements and project timelines, and recognise project training needs, including multiple/complex projects.
- Pro-actively address changing timelines, risks, priorities and resourcing requirements in line with appropriate issue escalation processes.
- Ability to establish and enforce the appropriate standards for multiple projects.
- Ability to monitor project progress.
Line Management Role
- Responsible for the line management of up to six programmers.
- Perform an active role in the development of direct reports and/or provide training, mentorship and support for programmers as necessary.
- Approve the timesheets of direct reports and review the timesheet entries which impact functional Key Performance Indicators.
- Supervision of direct reports through fortnightly or monthly meetings (as a minimum) and provision of day-to-day support on an informal ongoing basis, as required.
- Perform annual and interim reviews in accordance with HR processes and SOPs for direct reports.
- Implementation of all processes applicable to the role of a Line Manager.
- Ensure awareness of billability and other Key Performance Indicator targets.
- Responsible for monitoring team resource allocation
- Have input to recruitment and retention of staff within Quanticate.
Key Contacts/Relationships (Internal & External)
Internal
- Work closely with Project Delivery Managers, Portfolio Managers/Director/VP, the Senior VP Portfolio Management, Head of Programming, Head of Statistics, programming project teams, Data Managers and Medical Writers for the successful delivery of programming activities.
- Work in Partnership with support functions including HR, Finance, IT and BD.
External
- Interacts extensively with the client to complete various programming activities. To fulfil this role, the Principal Programmer may be required to be a key participant and/or lead project team meetings.
Person Specification
Education:
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Understanding of basic statistics.
Work Experience:
- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Preferably have programming experience covering activities from study set-up to final reporting.
Skills:
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
Senior Programmer
About the Company:
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Objectives:
- Technical expertise in support of project deliveries and training development of Programming personnel.
- Provide project and technical support, or line management support in the preparation and review of high-quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
Procedures:
Core
- Deliver excellent customer care in support of genuine value and a great customer experience.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Good knowledge of pharmaceutical industry standards
- Comprehensive understanding of current Quanticate, and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Provide mentoring in area of technical expertise.
- Ability to work with different, functions, and across sites, as required.
- Ability to review clinical documents, e.g. protocol, CRF and SAP.
- Demonstrated SAS programming knowledge to an advanced level with expected results in SAS competency test.
- Provide programming expertise and support within the function on programming standards, processes and procedures.
- Provide high quality deliverables and appropriate communication to the client within expected timelines and budget as directed by the Project Lead.
- Ability to represent the Company at external conferences, forums and working groups from a clinical programming perspective.
Key Contacts/Relationships (Internal & External)
Internal
- Has a close working relationship with Senior Programmers (all levels), Line Manager, HR and other functional staff.
- May deputise for a Senior Programmer II.
- Works closely with the project study teams (statisticians, clinicians, medical writers, project management) for the successful delivery of programming activities.
External
- Some interaction with clients to complete various programming activities. To fulfil this role, the Senior Programmer I may be required to be a key participant in project team meetings and be responsive on an ad hoc basis.
Person Specification
Education:
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Understanding of basic statistics.
Work Experience:
- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Preferably have programming experience covering activities from study set-up to final reporting.
Skills:
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
About the Company
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Objectives:
- Provide high quality statistical support to clients, which conforms to current Quanticate and client-specific standard operating procedures (SOPs) and processes, and to applicable regulatory requirements.
- Act as a lead point of contact with clients and accountable for enhancing customer satisfaction Lead cross-function operational teams to ensure successful delivery of projects.
Procedures:
- Provide high quality statistical support to studies including design and analysis of studies, writing SAPs and selecting optimum statistical methods, statistical sections of study protocols, estimates of sample size, and statistical general consultancy including study design and conduct.
- Work as operational lead, ensuring tasks are appropriately delegated to members of the project team in line with the requirements of the project plan. Lead cross-function operational teams to ensure successful delivery of projects.
- Monitor the work of the project team, and coordinate project delivery on time and within budget.
- Provide regulatory and submission support (PSUR, BB, DSMB, etc.)
Key Contacts/Relationships (Internal & External)
Internal
- Work closely with their line manager to review objectives, progress and development.
- Work closely with Senior and Principal Project Delivery Managers, Portfolio Managers/Director/VP, the Senior VP of Portfolio Delivery and Head of Programming and Statistics PMO allocated project teams, Senior Programming and Statistics staff, Group Managers, Clinicians and Medical Writers for the successful delivery of statistical activities.
- Work in Partnership with support functions including HR, Finance, IT and BD.
- Lead Statisticians, Senior Statisticians and Programmers assigned to projects to coordinate successful delivery of the required deliverables.
External
- Interact extensively with clients (including client PoC, statisticians, clinicians, medical writers, project managers) to lead the client relationship and successfully deliver statistical output, ensuring excellent customer care.
- Represent the company at external conferences and forums
Person Specification
Education:
- Qualified minimally to MSc level in Statistics or equivalent.
And/or:
- Have relevant experience within the pharmaceutical industry or medical sector.
- Understand the principles and procedures of statistics.
Skills:
- Strong statistical skills enabling independent provision of statistical advice and document review across a broad range of statistical applications.
- Good knowledge of SAS and experience with other statistical software.
- Proven ability to lead projects / Strong analytical and problem-solving skills.
- Significant experience in more than one study phase, with good understanding of all phases.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
For an informal chat please contact Andrew.Dixon@quanticate.com or connect with me via LinkedIn.
Senior SAS Programmer
About the Job:
For this role we are looking for strong technical applicants with experience in SAS programming and SQL. Rather than clinical research projects this role will work across real world evidence projects.
This role would suit experienced programmers who want to get experrience in life sciences.
About the Organisation:
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotech’s that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Objectives:
- Technical expertise in support of project deliveries and training development of Programming personnel.
- Provide project, technical support and line management support in the preparation and review of high-quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) Standard Operating Procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Ensure high levels of customer care are provided.
- Expert technical proficiency in the handling of large datasets.
- Use longitudinal databases (Administrative medical and pharmacy claims databases, Electronic Medical Records, Survey data).
- Create training materials as per guidance
Procedures: Core
- Deliver excellent customer care in support of genuine value and a great customer experience.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Excellent knowledge of pharmaceutical industry standards
- Comprehensive understanding of current Quanticate, and client-specific SOPs and processes, as well as applicable regulatory requirements and/or client related guidelines.
- Participate in new macro creations as per guidance.
- Work on complex projects (study type) and contribute to publications/regulatory submissions.
- To develop custom programming code to generate summary tables, listings, graphs and derived datasets as defined in the request description, Statistical Analysis Plan (SAP) or study protocol using SAS or any other software.
- To develop custom programming code to generate statistical models as defined in the request description, SAP or study protocol
- To set new priority goals provided by management, balancing the scheduled activities and time, to ensure all work is completed to a high quality, on time and within budget.
- Attend internal meetings, minutes to be recorded promptly and shared with all participants and follow up on action items till their completion without losing focus on future meetings, programming requirements and deadlines.
- Maintenance of project documentation, quality control documents and programs conforming to audit readiness.
- Mentor new programmers by developing training courses, presenting training materials, reviewing work and providing feedback.
- Ability to work with different functions, and across global sites as required.
- Perform other reasonable programming tasks as requested by management.
- Follow appropriate Project Management procedures.
- Work to the appropriate standards of the project.
- Ability to work independently as a programmer.
- Provide programming expertise and support within the function on programming standards, processes and procedures.
- Actively look for ways to increase efficiency.
- Provide high quality deliverables and appropriate communication to the client within expected timelines and budget.
- Provide technical input on study design, database selection, Real World Data (RWD) algorithms and best practices in RWD utilization.
- Excellent understanding of Outcomes Research (OR) macros
- Ability to represent the Company at external conferences, forums and working groups from a clinical programming perspective.
- Contribute and facilitate SAS training and workshops and other programming-related training sessions as applicable.
- To be responsible and accountable for daily and accurate completion of timesheets.
Key Contacts/Relationships (Internal & External)
Internal
Has a close working relationship with the Programming Department, Line Manager, HR and other functional staff.
Work closely with OR team members, the project study teams for the successful delivery of programming activities.
External
Interaction with Client Point of Contact (PoC) and interaction with Project Requestor/Statisticians/Data Scientists to complete various programming activities. To fulfil this role, the Senior Programmer I may be required to participate in project team meetings and be responsive on an ad hoc basis.
Person Specification
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Basic understanding of statistical models used in OR and being able to adapt statistical analysis code for the OR programming
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good knowledge of SQL, good organisational skills, good communication skills (oral and written), good analytical skills and attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
About the Job:
For this role we are looking for strong technical applicants with experience in SAS programming and SQL. Rather than clinical research projects this role will work across real world evidence projects.
This role would suit experienced programmers who want to get experience in life sciences.
About the Organisation:
Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotech’s that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Objectives:
- Further development of knowledge of SAS and advanced SQL, good programming practices and numerous Real World Data (RWD) databases.
- Ability to manage time and keep Client informed about project progress.
- Ensure high levels of customer care are provided.
- Review available resources to find required information
- Use and manipulate data stored in SQL database.
- Ability to understand and modify SAS macros.
- Use longitudinal databases (Administrative medical and pharmacy claims databases, Electronic Medical Records).
- Technical experience in handling large datasets.
- Basic understanding of statistical models used in Outcomes Research (OR)
- Ability to ask questions effectively.
Procedures: Core
- Undertake training as directed by line management and mentor.
- Deliver excellent customer care in support of genuine value and a great customer experience.
- Provide high quality deliverables and appropriate communication to the client within expected timelines.
- Program tables, figures and listings and derived datasets according to the request description.
- Perform quality control checks and complete quality control documentation for programming plans, specifications, outputs/derived datasets.
- Perform other reasonable programming tasks as requested by management.
- Have a good understanding of ICH/GCP guidelines.
- Demonstrate understanding of current Quanticate, and client-specific Standard Operating Procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Follow appropriate Project Management procedures.
- Work to the appropriate standards of the project.
- Communicate effectively with OR team.
- Provide input to improvements to processes, procedures and standards.
- Support the training and development of other programmers.
- Mentor Graduate programmers
- To be responsible and accountable for daily and accurate completion of timesheets.
Key Contacts/Relationships (Internal & External)
Internal
Work closely with the Programming Department, OR team members, mentor and line manager.
External
Interaction with Client Point of Contact (PoC) and limited interaction with Project Requestor/Statisticians/Data Scientists to complete various programming activities. Programmer II may be required to participate in project team meetings and be responsive on an ad hoc basis.
Person Specification
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good knowledge of SQL, good organisational skills, good communication skills (oral and written), good analytical skills and attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
- Multi-discipline role, with focus on delivering:
- Project leadership of assigned complex/multiple projects and/or
- Line management of assigned personnel and/or
- Technical oversight in support of Operations deliveries, projects, initiatives, and training development of Programming personnel.
- Lead process improvement and knowledge-sharing within the function.
- Provide advanced project and technical support in the preparation and review of high quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Input to the development of the Programming function and its staff, including encouraging and supporting commercial awareness.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Ensure consistently high levels of customer care are provided.
Lead Principal Programmer
About the Job:
For this role we are looking for strong technical applicants. Rather than leading projects this role will work across projects offering advice and support on the technical side whether that is resolving challenges or mentoring junior professionals on how to complete them. Though not a direct leadership role you will be mentoring staff. You will be supporting the Head of Programming on project delivery and will have great visibility in the company and with the CEO and COO.
This role would suit experienced programmers who want to stay 'hands on' rather than moving into management.
About the Organisation:
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotech’s that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Objectives:
- Multi-discipline role, with focus on delivering:
- Project leadership of assigned complex/multiple projects and/or
- Line management of assigned personnel and/or
- Technical oversight in support of Operations deliveries, projects, initiatives, and training development of Programming personnel.
- Lead process improvement and knowledge-sharing within the function.
- Provide advanced project and technical support in the preparation and review of high quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Input to the development of the Programming function and its staff, including encouraging and supporting commercial awareness.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
Procedures:
Core
- Deliver outstanding customer care in support of genuine value and a great customer experience.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Comprehensive knowledge of pharmaceutical industry standards.
- Comprehensive understanding of current Quanticate, and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Ensure adherence to all relevant SOPs, guidelines and processes.
- Maintain up-to-date knowledge of the external regulatory environment relating to programming, including ICH/GCP requirements, and provide advice and educate colleagues (and clients) on changes to regulatory requirements and/or other guidelines relating to programming.
- Provide high quality deliverables and appropriate communication within expected timelines and budget.
- Use acquired in-depth knowledge and broad expertise to create, update and enhance procedures and applicable SOPs within Programming.
- Identify, develop and lead cross-functional initiatives promoting knowledge-sharing within Quanticate.
- Provide mentoring and leadership, as required.
- Ability to perform Peer Review or Final Inspections, locally or globally, as required.
- Ability to critically review and provide comments on clinical documents, e.g. protocol, CRF and SAP.
- Ability to represent the Company at external conferences and forums.
- May become involved in industry initiatives and organisations (e.g. PhUSE Committees/Steering bodies).
- Participate in meetings such as recruitment, business development, finance and audits from a clinical programming perspective.
- Perform other reasonable tasks as requested by management.
- Assist with the implementation of and follow appropriate Project Management procedures.
- Input to the development of functional goals and objectives.
- Take responsibility for a functional objective.
- To be responsible and accountable for daily and accurate completion of timesheets.
- To ensure that all direct reports are actively encouraged and reminded of the need for daily and accurate completion of timesheets and to closely monitor the completion metrics.
Technical Ability
- SAS Programming knowledge and experience to enable oversight of programming teams.
- Provide programming advice internally and externally on complex clinical projects.
- Oversee the delivery of consistently high quality output in a timely manner.
- Ability to identify departmental technical training requirements.
- Oversee and/or develop/deliver SAS training and workshops and other related training sessions, as applicable.
- Encourage the acquirement of SAS, industry trends, other appropriate programming expertise and standards within Programming.
Project Management Ability
- Comprehensive knowledge of regulatory agency guidelines.
- Ability to plan resource requirements and project timelines, and recognise project training needs, including multiple/complex projects.
- Pro-actively address changing timelines, risks, priorities and resourcing requirements in line with appropriate issue escalation processes.
- Ability to establish and enforce the appropriate standards for multiple projects.
- Ability to monitor project progress.
Line Management Role
- Responsible for the line management of up to six programmers.
- Perform an active role in the development of direct reports and/or provide training, mentorship and support for programmers as necessary.
- Approve the timesheets of direct reports and review the timesheet entries which impact functional Key Performance Indicators.
- Supervision of direct reports through fortnightly or monthly meetings (as a minimum) and provision of day-to-day support on an informal ongoing basis, as required.
- Perform annual and interim reviews in accordance with HR processes and SOPs for direct reports.
- Implementation of all processes applicable to the role of a Line Manager.
- Ensure awareness of billability and other Key Performance Indicator targets.
- Responsible for monitoring team resource allocation
- Have input to recruitment and retention of staff within Quanticate.
Key Contacts/Relationships (Internal & External)
Internal
- Work closely with Project Delivery Managers, Portfolio Managers/Director/VP, the Senior VP Portfolio Management, Head of Programming, Head of Statistics, programming project teams, Data Managers and Medical Writers for the successful delivery of programming activities.
- Work in Partnership with support functions including HR, Finance, IT and BD.
External
- Interacts extensively with the client to complete various programming activities. To fulfil this role, the Principal Programmer may be required to be a key participant and/or lead project team meetings.
Person Specification
Education:
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Understanding of basic statistics.
Work Experience:
- Very experienced SAS programmer within CRO/life sciences area.
- Very good knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Programming experience covering activities from study set-up to final reporting.
Skills:
- Should have strong PC skills, very good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
We have an exiting opportunity for "Project Planner" who would support Project Delivery Managers in the build and maintenance of MSP plan
These positions (3 Vacancies) offer a fantastic opportunity to join a dedicated Statistics department. As a Graduate Statistician, you will have the opportunity to further develop your clinical statistics knowledge as well as gain experience in multiple therapeutic areas.
This is an office based role, you will be expected to spend the first year with 5 days a week in office to aid in training. You will be following a development plan designed to give you the knowledge you need to excel within the company. Following your first year it would be a hybrid model with 2-3 days in the office.
You will gain exposure to a broad range of clinical trial studies, working across Phases I-IV in a wide variety of therapeutic areas. Working as part of local and global project teams, you will have the opportunity to work on high profile, global studies for major pharmaceutical clients.
These positions (3 Vacancies) offer a fantastic opportunity to join a dedicated programming department. As a Graduate SAS Programmer, you will have the opportunity to gain foundation knowledge of SAS programming, developing good programming techniques for clinical trial reporting.
This is an office based role, you will be expected to spend the first year with 5 days a week in office to aid in training. You will be following a development plan designed to give you the knowledge you need to excel within the company. Following your first year it would be a hybrid model with 2-3 days in the office.
Quanticate has a Fast Track Program which works to identify your strengths and ascertain your interests, and then develop a personal training plan to help you to reach your career goals. You will experience rapid promotion through the Programming grades, enabling those capable to become leads on multiple clinical projects at a more junior level. Employees at Quanticate can progress through the three levels of Programming every 6 months, which means that within two years, you could become a Senior.
You will gain exposure to a broad range of clinical trial studies, working across Phases I-IV in a wide variety of therapeutic areas. Working as part of local and global project teams, you will have the opportunity to work on high profile, global studies for major pharmaceutical clients.
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Location: Bangalore/ Hyderabad (Office Based/Hybrid)
- To provide functional leadership in Medical Writing and ensuring consistent processes and excellence in providing planning, execution, and delivery of all types of scientific reports
- To recruit, train and retain a highly skilled workforce of medical writers to support clients’ projects
- To ensure that the Medical Writing function meets time, quality, and cost targets consistent with being an efficient and effective business unit
- To advise on regulatory standards and appropriate guidelines
- To maintain the resource model and assign projects to appropriate personnel
Quanticate, the Biostatistics and Data Experts are engaging with suitably experienced statistical programming professionals for the role of Principal Programmer. The permanent role will be instrumental in delivering Quanticate client services within the Clinical Trial, Research, Pharmaceuticals spaces.
Working at Quanticate offers a career with variety, exposure to clients, and an excellent culture of learning, development and career transformation.
You will be part of an inclusive and diverse organisation that has adapted and innovated for over 28 years. Our senior level roles are key to the quality of our deliverables. They perform the direct validation of other programmers’ work and support, train, and mentor Quanticate juniors and peers alike. Initiatives such as the on-going delivery of R training powers our programmers with the tools and technical expertise to adapt to an ever-changing industry.
We offer remote working from anywhere in the United Kingdom with hybrid, flexible and on-site options. A warm welcome awaits you in our Manchester City and Hitchin - Hertfordshire locations.
Objective/Role mission statement
- To deliver technical expertise in support of project deliveries, and the training and development of programming personnel.
- To provide project and technical support, or line management support in the preparation and review of highquality programming deliverables and documentation, as well as the processes and standards required.
- To provide best-in-class, high quality, efficient support that ensures delivery in line with Quanticate/client standard operating procedures (SOPs) and processes.
- To ensure all applicable regulatory requirements are met and guidelines followed on behalf of the client and Quanticate.
What we’re looking for
- Demonstratable SAS programming knowledge (R, SPSS, SQL, ADaMS would be beneficial)
- Experience of clinical/pharmaceutical drug development and associated ICH/GCP guidelines
- Experience reviewing clinical documents, e.g., Protocol, SDTM, eCRF, SA.
- Good knowledge of pharmaceutical industry standards
- Experience delivering SAS training/workshops and other programming-related training sessions
What we offer you
- 25 days annual leave + bank holidays
- Holiday purchase scheme
- Fully remote +hybrid options - Rural and City locations including Hitchin, Manchester
- Flexible working hours
- Life Cover
- Extensive training culture
- Employee wellbeing support to all staff
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Responsibilities
- Provide project and technical support, or line management support in the preparation and review of high-quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Ability to review clinical documents, e.g. protocol, CRF and SAP.
- Ability to represent the Company at external conferences, forums and working groups from a clinical programming perspective.
- Contribute to SAS training and workshops and other programming-related training sessions as applicable.
Skills & Qualifications
- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
For an informal chat please contact lizzie.fitch@quanticate.com or connect with me via LinkedIn.
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Responsibilities
- Provide project and technical support, or line management support in the preparation and review of high-quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Ability to review clinical documents, e.g. protocol, CRF and SAP.
- Ability to represent the Company at external conferences, forums and working groups from a clinical programming perspective.
- Contribute to SAS training and workshops and other programming-related training sessions as applicable.
Skills & Qualifications
- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
For an informal chat please contact lizzie.fitch@quanticate.com or connect with me via LinkedIn.
Senior Programmer
About the job:
Quanticate is the world leading data-focussed CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming input. We need talented individuals to help us fulfil our customers’ needs.
Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical programme, to small biotechs that are taking their first steps in clinical development
We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.
Job Specification
Objectives:
- Technical expertise in support of project deliveries and training development of Programming personnel.
- Provide project and technical support, or line management support in the preparation and review of high-quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
- Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
Procedures:
Core
- Deliver excellent customer care in support of genuine value and a great customer experience.
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
- Good knowledge of pharmaceutical industry standards
- Comprehensive understanding of current Quanticate, and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
- Provide mentoring in area of technical expertise.
- Ability to work with different, functions, and across sites, as required.
- Ability to review clinical documents, e.g. protocol, CRF and SAP.
- Demonstrated SAS programming knowledge to an advanced level with expected results in SAS competency test.
- Provide programming expertise and support within the function on programming standards, processes and procedures.
- Provide high quality deliverables and appropriate communication to the client within expected timelines and budget as directed by the Project Lead.
- Ability to represent the Company at external conferences, forums and working groups from a clinical programming perspective.
Key Contacts/Relationships (Internal & External)
Internal
- Has a close working relationship with Senior Programmers (all levels), Line Manager, HR and other functional staff.
- May deputise for a Senior Programmer II.
- Works closely with the project study teams (statisticians, clinicians, medical writers, project management) for the successful delivery of programming activities.
External
- Some interaction with clients to complete various programming activities. To fulfil this role, the Senior Programmer I may be required to be a key participant in project team meetings and be responsive on an ad hoc basis.
Person Specification
Education:
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Understanding of basic statistics.
Work Experience:
- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
- Preferably have programming experience covering activities from study set-up to final reporting.
Skills:
- Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.
At Quanticate, our people are our focus, as we understand that they are the key to our success. We strongly believe in work-life balance by offering flexible working arrangements, competitive salary, excellent benefits package and access to tools and computing systems including both SAS and R.
- Provide high quality statistical support to clients, which conforms to current Quanticate and client-specific standard operating procedures (SOPs) and processes, and to applicable regulatory requirements.
- Act as a lead point of contact with clients and accountable for enhancing customer satisfaction.
- Provide project leadership of assigned projects and ensure project budgets are monitored and maintained and that issues and risks are effectively communicated within the organisation and with partners and clients.
- Contribute to business development activities to maintain and attract contracts involving statistical work components.
- Lead process improvement and knowledge sharing within and across functions.
- Provide advanced technical support in the delivery of projects across the function.
- Lead cross-function operational teams to ensure successful delivery of projects.
- Ensure high levels of customer care are provided by self and team.
- Responsible and accountable for daily and accurate completion of timesheets.
- Ensure that all direct reports are actively encouraged and reminded of the need for daily and accurate completion of timesheets and to closely monitor the completion metrics.