Senior Principal Statistician
Core
Lead statistical strategy and execution for clinical trial programs to ensure regulatory compliance and scientific rigor in drug development.
Role type
Senior Principal Statistician (Clinical Development)
Builds
Clinical trial protocols, statistical analysis plans, regulatory submissions, and scientific publications.
Domain
Pharmaceutical/Biotech clinical development and regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial methodology, advanced statistical methods, SAS, R, CDISC standards, regulatory interactions, study design strategy, mentorship
Preferred skills
Experience in obesity/diabetes/cardiovascular disease, cross-functional global team leadership, multi-phase drug development experience
Technologies
SAS, R
Responsibilities
Lead statistical design and strategy for molecule programs; author statistical analysis plans and protocols; perform or oversee data analyses for clinical trials; mentor junior statisticians; communicate results to health authorities and internal stakeholders; drive continuous improvement of statistical processes.
Seniority
Principal, strategic leadership with hands-on technical execution