Principal Biostatistician (EU-based, Remote)

About the role

Syneos Health is hiring a Principal Biostatistician, EU-based and working remotely, who leads projects across multiple studies or programs. The Principal acts as the primary contact with the sponsor on biostatistics matters, provides external statistical consultancy and serves as a departmental resource for complex statistical questions, study design and protocol development.

Key responsibilities

• Mentor biostatisticians, oversee training plans and conduct training sessions for new hires and existing staff.
• Direct the work of other biostatistics personnel on projects, provide independent review of their work and support statistical tasks from protocol to CSR.
• Prepare or oversee Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings and figures; may lead the statistical aspects of the protocol, randomization schedule and the clinical study report.
• Create or review programming specifications and review SAS annotated CRFs, database design and other documentation.
• Conduct verification and quality control of deliverables, maintain project documentation and inspection-readiness files, and support business development activities such as proposals, budgets and sponsor bid defenses.
• May lead complex or multiple projects (e.g., submissions, integrated analyses), attend regulatory agency meetings, and take part in DSMB/DMC activities, including as a voting statistician.
• Manage schedules and time across multiple projects, escalate out-of-scope tasks and adapt to timeline changes.

Required profile

• Master's degree in biostatistics or a related discipline (minimum).
• Hands-on integrated analysis experience, including IASAP and TLF specifications, derivations, draft table reviews and analysis planning for labeling.
• Strong submission and clinical development expertise, including submission planning and benefit/risk analyses.
• Ability to manage regulatory authority requests and partner with clinical teams; regulatory submission experience preferred.
• Extensive clinical trial experience or an equivalent combination of education and experience, able to lead multiple projects.
• Excellent written and verbal communication skills and English proficiency.

Required skills

• Proficiency in programming.
• Knowledge of statistical design, analysis, regulatory guidelines (e.g., ICH) and programming techniques used in clinical research.
• Experience across all statistical tasks from protocol to CSR.