Lead Statistical Programmer, Oncology, Single Sponsor

hace 6 días

Madrid, Madrid, España Mai Fortrea Development Limited A tiempo completo
About the Role

Mai Fortrea Development Limited is seeking a highly skilled Lead Statistical Programmer to join our team in the Oncology department. As a Lead Statistical Programmer, you will play a critical role in the successful delivery of complex oncology projects for a renowned pharmaceutical company.

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.
  • 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).
  • Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing 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
  • 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 oncology clinical trials (minimum 5 years) and the corresponding datasets' content (safety and efficacy) and endpoints.
  • Lead experience in Oncology trials (from pharma or CRO perspective).
  • Ideally, you will have 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 Reviewer's Guides and submission standards.
  • An autonomous, collaborative work style, a curious mind, and a keen attention to detail.
  • Fluency in English both verbal and written is a must.

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