Principal Statistical Programmer - Sponsor Dedicated

January 30

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Fortrea

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Fortrea is a clinical research organization (CRO) with over 30 years of experience dedicated to accelerating the development of life-changing treatments by providing comprehensive clinical solutions for biopharma and MedTech companies. They offer a range of services including clinical trial management, pharmacology services, and regulatory strategy, all designed around the needs of their clients. Fortrea's mission is to put patients at the center of their work, aiming to bring innovative therapies to market faster through tailored, data-driven approaches.

clinical research • clinical trials

10,000+ employees

💊 Pharmaceuticals

📋 Description

• Plan, execute and oversee all programming activities on a study, including but not limited to: resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments, etc. • 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

• Ideally, 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 data sets content (safety and efficacy) and endpoints • 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 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