Principal Biostatistician (Associate Director Level)
Core
Lead statistical design and analysis for early-phase clinical trials (Phase I/II) to guide go/no-go decisions and regulatory interactions.
Role type
Principal Biostatistician (Associate Director Level)
Builds
Statistical analysis plans, regulatory submission content (INDs, EMA packages), and strategic frameworks for early development.
Domain
Biopharmaceuticals / Clinical Development / Early Development Biometrics
Required skills
Advanced clinical trial statistics, Adaptive/Bayesian trial design, SAS, R, CDISC standards, Regulatory submission strategy, High-dimensional data analysis
Preferred skills
Cross-functional global team leadership, First-in-human study experience, Omics/Imaging/Real-world data integration, Mentoring, Strategic portfolio decision-making
Technologies
SAS, R, CDISC
Responsibilities
Lead statistical design of complex early phase studies; Champion innovative methodologies like Bayesian designs; Ensure strategic alignment and quality across statistical deliverables; Solve complex statistical challenges with translational data; Interpret emerging data for stakeholders; Own statistical content for major regulatory submissions; Lead sub-streams integrating novel data sources.
Seniority
Principal, strategic leadership & hands-on IC