Principal Biostatistician - FSP Europe
Core
Strategic statistical leadership for Phase I–III clinical trials, including study design, protocol development, and analysis of results to support regulatory submissions.
Role type
Principal Biostatistician
Builds
Clinical trial statistical strategies and analysis plans for pharmaceutical and biotechnology clients
Domain
Clinical research, biostatistics, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Biostatistics, SAS programming, ICH-GCP guidelines, Statistical Analysis Plans (SAPs), regulatory submission support, multi-study management, technical mentorship
Preferred skills
CDISC standards, R, EAST, WinBUGS, autoimmune/oncology therapeutic areas, vendor management
Technologies
SAS, R, EAST, WinBUGS
Responsibilities
Lead statistical activities for Phase I–III clinical trials; contribute to study design and protocol development; develop and review Statistical Analysis Plans; oversee statistical analyses and interpretation of results; support regulatory submissions and interactions with health authorities; provide technical expertise and mentorship on biostatistical methodologies; manage multiple studies and priorities
Seniority
Principal, strategic leadership & mentorship
