Senior Statistical Programmer Job Description
As Senior Statistical Programmer, you will provide technical expertise for the conduct of clinical trials, where you will act as an internal subject matter expert in specific areas providing technical support and expert advice, and work independently to support various programming activities related to the analysis and reporting of clinical study data.
Further responsibilities of this Senior Statistical Programmer job will include:
- Deliver best value and high quality service
- Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
- Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
- Monitor project resourcing, project budgets, and identify changes in scope
- Interact with Sponsors as the key contact with regard to statistical programming issues
- Provide technical support and advice to the internal team
- Check own work in an ongoing way to ensure first-time quality
- Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
- Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spread sheets, and required documentation.
- Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
- Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
- Create standard macros and applications to improve the efficiency of the department.
- Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
- Proactively participate in and/or lead process/quality improvement initiatives
- Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
- Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
As Senior Statistical Programmer you will have the following qualifications, skills and experience:
- A BSc Degree in a Life Sciences, Computer Science, Mathematics, Statistics OR Equivalent
- proven experience of working in a Pharmaceutical/CRO/Biotechnology organisations
- A proficient user of SAS and hold knowledge of the programming and reporting process
- The ability to learn new systems and function in an evolving technical environment
- The ability to successfully work together within a team as well as independently
How to apply:
For more information or to apply, please contact Priya Mukherjee on +44(0)1438 870028 or email firstname.lastname@example.org.