Principal Statistical Programmer - Sponsor Dedicated, EMEA
Key Skills for This Role
Full Job Posting
Your Responsibilities
- 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.
Your Profile
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.
Learn more about our EEO & Accommodations request here .
About Fortrea
Global contract research organization providing clinical development solutions.
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