Principal Statistical Programmer, Single Sponsor

1 month ago

Maidenhead, Windsor and Maidenhead, United Kingdom MAI Fortrea Development Limited Full time
About the Role

As a Principal Statistical Programmer at Fortrea, you will play a critical role in the successful delivery of complex projects for a renowned pharmaceutical company. Your expertise in statistical programming will be instrumental in overseeing studies from the Pharma side, ensuring timely and accurate results.

Key Responsibilities
  • Plan, execute, and oversee all programming activities on a study, including resource estimation, working within budget, meeting timelines, and maximizing quality.
  • 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 clinical trials (minimum 5 years) and the corresponding datasets' content (safety and efficacy) and endpoints.
  • 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.
  • Fluency in English – both verbal and written – is a must.
About Fortrea

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

We are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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