Principal Biostatistician
Core
Manage biostatistics operations for clinical development programs, ensuring high-quality design, analysis, reporting, and interpretation of clinical trial data.
Role type
Principal Biostatistician (Lead Statistical SME)
Builds
Clinical trial data packages for regulatory submissions and scientific publications
Domain
Healthcare / Clinical Development / Biostatistics
Required skills
Clinical development biostatistics, Statistical methods, SAS programming, R programming, CDISC standards (SDTM/ADaM), Regulatory submission support, Vendor oversight
Preferred skills
PhD in Statistics, Cross-functional collaboration, Risk management, Team leadership
Technologies
SAS, R, CDISC
Responsibilities
Lead and manage biostatistics operations for clinical development programs; Serve as Lead Statistical SME applying appropriate statistical methodologies; Oversee statistical activities at the project level including vendor oversight; Collaborate cross-functionally to support project success and publication strategies; Provide statistical support for regulatory submissions and interactions with health authorities; Support clinical investigators with statistical input and data interpretation.
Seniority
Principal, hands-on IC with management responsibilities