Principal Statistician – Early Phase – Remote Europe

About the role

Lead the development and execution of early‑phase clinical development plans, providing statistical strategy, mentorship and oversight across multiple projects. This fully remote position supports sponsors throughout the trial lifecycle, from protocol design to final CSR.

Key responsibilities

• Define Go/No‑Go frameworks and use simulations to influence trial design decisions.
• Mentor biostatisticians, develop training materials and oversee the work of statistical teams.
• Prepare and review Statistical Analysis Plans, mock‑up displays, and programming specifications for datasets, tables, listings and figures.
• Provide statistical support from protocol development through CSR, including randomization schedule generation and regulatory submission assistance.
• Participate in DSMB/DMC activities, regulatory agency meetings and ensure compliance with SOPs and ICH guidelines.

Required profile

• Master's degree in biostatistics or a related discipline.
• Extensive experience leading multiple clinical trial projects and contributing to development strategy.
• Strong written and verbal communication skills in English.
• Ability to manage timelines, prioritize tasks and work collaboratively with cross‑functional teams.

Required skills

• Proficiency in R programming.
• Experience with SAS for data handling and analysis.
• Deep knowledge of statistical design, analysis methods and relevant regulatory guidelines (ICH, FDA, EMA).