Statistical Programming Expert for Oncology Clinical Trials

4 days ago


Maidenhead, Windsor and Maidenhead, United Kingdom Lifelancer Full time
About the Role

We are seeking an experienced Statistical Programmer to join our team in a Senior role. In this position, you will be responsible for developing and validating SAS programs for data presentations and analyses, as well as providing programming support to your global project team.

This is an excellent opportunity to participate in the development of innovative Oncology drugs, with a direct impact on improving the health and lives of thousands of patients around the globe every day.

Key Responsibilities
  • Review SAPs and TFL shells from a programming perspective and advise on their development.
  • Develop complex specifications for SDTMs and ADaM datasets, as well as lead the development of these specifications.
  • Create SDTM and ADaM datasets, TFLs, and other deliverables using SAS programs.
  • Perform quality control checks on SDTM, ADaM, and TFL outputs.
  • Respond to QA and client audits, supporting qualification audits as needed.
  • Identify and propose improvements to efficiency, quality, and productivity in clinical statistical programming.
Your Profile
  • Degree in mathematics, life sciences, statistics, computer sciences, or equivalent completed vocational training and/or professional experience in statistical programming for clinical trials.
  • Solid professional experience as a statistical programmer in biotech, CRO, or pharmaceutical companies.
  • Demonstrated knowledge of base SAS, SAS macros, and SAS/STAT, with ability to debug SAS programs.
  • Proven experience with SDTMs, ADaM datasets (safety and efficacy), and TFLs.
  • Familiarity with CDISC standards and prior experience working on oncology data (safety and efficacy) and/or vaccine trials.
  • Submission experience is highly desirable.
  • Strong organizational skills, autonomous work style, curious mind, and attention to detail.


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