Principal Statistical Programmer – Sponsor Dedicated
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Job Description
Principal Statistical Programmer in sponsor-dedicated Flexible Solutions business unit for global pharmaceutical company. Overseeing programming activities in clinical trials with opportunities for career growth.
Responsibilities:
- 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
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