- Paris, Île-de-France, France
- Senior
- 10+ years
Lead and mentor a team of biostatisticians in rare disease clinical development, providing statistical expertise, regulatory submissions, and strategic guidance.
Responsibilities
- Lead and mentor biostatisticians
- Provide strategic support to asset teams
- Author and review study documents (protocol, SAP, dataset specifications, clinical study report, publications, regulatory submissions)
- Coordinate planning and execution of biostatistics deliverables
- Ensure quality, accuracy, and adherence to timelines
Requirements
- MS in statistics or biostatistics (required)
- PhD in statistics or biostatistics (preferred)
- Nice to have: Rare disease drug development experience
- Nice to have: Regulatory submission experience (US FDA, EMA, PMDA)
- Nice to have: PhD in statistics or biostatistics