Principal Statistical Programmer – Sponsor Dedicated

This is a fully remote position, open to applicants in Europe.

📋 Description

• Plan, implement, and manage all programming activities for a study, including resource forecasting, adherence to budget, meeting deadlines, enhancing quality, and collaborating with other departments.

• Supervise the development of SDTM, ADaM, and TLF outputs, and conduct Senior Reviews of these outputs.

• Coordinate with other Sponsor departments for additional programming requirements.

• Assist and oversee submission activities, particularly within late-phase teams.

• Ensure that all activities are performed efficiently.

• Mentor junior team members on best practices related to SDTMs, ADaMs, and TFLs.

⛳️ Requirements

• A degree in a relevant discipline such as mathematics, life sciences, statistics, computer science, or similar is preferred.

• Professional experience in statistical programming within clinical trials, preferably in a biotech, CRO, or pharmaceutical setting.

• Extensive experience with complex clinical trials (minimum of 5 years) and familiarity with the associated datasets (safety and efficacy) and endpoints.

• Comprehensive understanding of all aspects of clinical trials, from initial setup to final completion.

• Awareness of the roles and responsibilities across all relevant disciplines.

• Proficient in base SAS, SAS macros, SAS/STAT, and skilled in debugging SAS programs.

• In-depth knowledge of all CDISC standards pertaining to SDTM and ADaM, including define.xml, Reviewer's Guides, and submission criteria.

• Independent and collaborative working style, with a curious mindset and strong attention to detail.

• Proficiency in English, both spoken and written, is essential.

🏝️ Benefits

• Flexible Solutions business unit.

• Opportunities for future career advancement.