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.
- 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.
- 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)
- 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.
- 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.
- Qualified to degree level or equivalent, preferably in a numerate discipline.
- Understanding of basic statistics.
- 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.
- 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.