Principal Biostatistician Medical Affairs ( UK, Ireland, Poland, Greece, Hungary, Romania, Ukra[...]

Principal Biostatistician Medical Affairs (UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, Netherlands)

Updated: July 7, 2026Location: Montrouge, FranceJob ID: -OTHLOC-3527-2DR

Job Description

Provide statistical support to the Medical Affairs group focused on exploratory analysis, observational studies, real‑world evidence, and publication support. Responsibilities include supporting projects from protocol through the Clinical Study Report, preparing Statistical Analysis Plans (SAPs), collaborating with sponsors, coordinating biostatistics personnel, and ensuring high‑quality deliverables.

Responsibilities

• Serve as statistical lead on projects, representing biostatistics on project teams.
• Prepare SAPs, mock‑up tables, listings and figures, and review study documents to meet protocol criteria.
• Coordinate and review the work of other biostatisticians and statistical programmers.
• Create or review programming specifications for analysis datasets and outputs.
• Perform verification and quality control of project deliverables, ensuring consistency with SAP.
• Lead projects involving integrated analyses, attend regulatory meetings, and respond to queries.
• Participate in Data Safety Monitoring Board / Data Monitoring Committee activities as an independent biostatistician.
• Maintain project documentation and quality control records for inspection readiness.
• Assist in business development activities such as proposals, budgets, and sponsor bid defense meetings.
• Coach and mentor biostatistics staff.
• Perform other related duties as assigned.

Qualifications & Requirements

• Must be located in UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, or Netherlands.
• Previous clinical experience within Clinical Trials required.
• Strong knowledge of statistical methods and industry regulatory guidelines (e.g., ICH).
• Excellent communication, teamwork, and organizational skills.

Travel

• Minimal travel may be required.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and/or education may be considered. All employment decisions comply with applicable laws and the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations.