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.