Remote job
Principal Statistician - Early Phase - Fully home based (remote anywhere in Europe) Sponsor Dedicated - Program/Project Leader
Job details
About this role
Role overview
Provide senior statistical leadership for early-phase clinical development programs, guiding study design and analysis from protocol planning through clinical study reporting. The role combines strategic advice, hands-on biostatistics, quality oversight, and project leadership, while supporting the development of statisticians across the team. The position is described as fully home-based and open to applicants located anywhere in Europe.
Responsibilities
- Shape clinical development plans and decision frameworks, using statistical strategy and simulation to inform trial design and progression decisions. - Lead statistical contributions across the study lifecycle, including protocol input, randomization planning, analysis planning, and clinical study reports. - Prepare or oversee statistical analysis plans and clear mock-ups for tables, listings, and figures; review analysis specifications and study documentation. - Check that case report forms, database design, and data capture support protocol requirements and planned analyses. - Direct and review work by other biostatistics staff, verify deliverables against plans and specifications, and help ensure high-quality, timely outputs. - Coordinate with clinical and other project functions, manage competing timelines, mentor colleagues, and contribute to training and sponsor discussions, including regulatory submissions when needed.
Requirements
- Master’s degree in biostatistics or a related discipline, or equivalent education and experience. - Extensive clinical trial experience and a track record of leading multiple projects or study programs. - Experience contributing to program-level decisions and clinical development strategy. - Proficiency in R and broad experience with statistical design, analysis, and programming methods used in clinical research. - Experience supporting statistical work from protocol through clinical study report, with the ability to explain statistical concepts clearly. - Excellent written and verbal English communication skills.
Nice to have
- Experience supporting regulatory submissions, integrated analyses, or responses to agency questions. - Minimal travel may be required.