Principal Biostatistician (Associate Director Level)
Core
Lead statistical design and analysis for early-phase clinical studies (Phase I/II) to guide trial strategy, de-risk development, and inform go/no-go decisions.
Role type
Principal Biostatistician (Associate Director Level)
Builds
Statistical analysis plans, regulatory submission content (INDs, EMA packages), and strategic frameworks for early clinical development.
Domain
Biopharmaceuticals / Early Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced statistical methods (Bayesian, adaptive designs), SAS, R, CDISC standards, regulatory data requirements, study-level strategy, regulatory submission leadership
Preferred skills
Cross-functional collaboration, early-phase drug development expertise, mentoring, strategic risk assessment, innovative methodology application
Technologies
SAS, R
Responsibilities
Lead statistical design of complex early phase studies; champion innovative methodologies; ensure strategic alignment and quality across deliverables; solve complex statistical challenges with emerging data; interpret data to drive internal narratives; own statistical content for major regulatory submissions; lead sub-streams integrating novel data sources (omics, imaging, RWD)
Seniority
Principal, hands-on IC with strategic leadership
