Principal Statistician
Core
Lead statistical planning and delivery for clinical research in Japan, designing trials, analyzing data, and supporting regulatory interactions.
Role type
Principal Statistician (Clinical Research)
Builds
Clinical trial designs, analysis plans, and regulatory submissions for vaccines and medicines
Domain
Biopharmaceuticals / Clinical Trials
Required skills
Clinical trial design, Statistical analysis, Regulatory submissions, Vendor management, Adaptive/Bayesian methods, R or SAS
Preferred skills
PhD in statistics/biostatistics, Direct regulatory authority interaction, Adaptive/Bayesian design expertise, Therapeutic area background, Vendor/statistician management, Data science tools
Technologies
R, SAS
Responsibilities
Lead statistical planning and delivery for Japan clinical projects; Design trials and prepare analysis plans; Collaborate with global teams to align trial design; Prepare input for regulatory interactions and submissions; Oversee external statistical partners and vendors; Coach and mentor statisticians and colleagues
Seniority
Principal, hands-on IC with leadership