Principal Statistical Programmer – Sponsor Dedicated

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🕒 April 23

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Plan, execute and oversee all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments • Oversee SDTM, ADaM and TLF development, perform Senior Review of outputs • Liaise with other Sponsor departments for additional programming needs • Support/oversee submission activities (especially in late phase team) • Ensure all activities are conducted efficiently • Mentor less-experienced team members in best practices around SDTMs, ADaMs and TFLs

🎯 Requirements

• Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc. • 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 • Knowledge in all aspects of clinical trials, from initial study set-up to study completion • Understanding of the roles and responsibilities of all related disciplines • 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 • Autonomous, collaborative work style, a curious mind and a keen attention to detail • Fluency in English – both verbal and written is a must

🏖️ Benefits

• Flexible Solutions business unit • Opportunity for future career growth