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Senior Statistical Programmer

1 month ago

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

We are seeking a highly skilled Senior Statistical Programmer to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT. As a Senior Statistical Programmer, you will play a crucial role in the successful delivery of complex projects for our renowned pharmaceutical clients.

Key Responsibilities
  • Plan, execute, and oversee all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, and interaction with other departments.
  • Oversee SDTM, ADaM, and TLF development, perform Senior Review of outputs, and ensure all activities are conducted efficiently with appropriate set-up of needed tools and macros.
  • Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing, and additional development needs and analyses.
  • Support/oversee submission activities, especially in late phase team, and ensure all activities are conducted with quality at all times.
  • Mentor less-experienced team members in best practices around SDTMs, ADaMs, and TFLs while ensuring adherence to department standards and processes.
Requirements
  • Ideal candidate has a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  • In lieu of the above, professional experience in statistical programming within clinical trials in a biotech, CRO, or pharmaceutical company.
  • Solid experience with complex clinical trials (minimum 5 years) and the corresponding datasets content (safety and efficacy) and endpoints.
  • Ideal candidate has knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g., Biostatistics and Clinical Data Management.
  • Expert knowledge of base SAS, SAS macros, SAS/STAT, and in debugging SAS programs.
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guides, and submission standards.
  • An autonomous, collaborative work style, a curious mind, and a keen attention to detail.
About Lifelancer

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. If you are passionate about working in a dynamic and innovative environment, we encourage you to apply for this exciting opportunity.