Associate Director, Late Phase Research Biostatistics
Core
Lead statistician providing leadership and guidance for late-phase clinical studies, ensuring statistical validity and strategy for observational and investigational designs.
Role type
Senior IC biostatistician with supervisory responsibilities
Builds
Clinical study reports (CSR), statistical methods/results sections, key results memos, and data packages for publication/decision-making
Domain
Pharmaceutical/Biotech, late-phase/post-marketing research, chronic pain management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Advanced statistical concepts, observational study designs, multivariable modeling, longitudinal data analysis, causal inference, SAS/R programming, project management, team leadership
Preferred skills
Experience with medical devices, gene therapy, external agency management (CROs)
Technologies
SAS, R
Responsibilities
Oversee statistical support for multiple project teams; define late-phase research strategy and protocols; conduct analyses and prepare CSR sections; review and approve statistical conclusions; mentor staff; manage project timelines and resources; ensure compliance with SOPs and regulatory requirements.
Seniority
Senior, hands-on IC with supervisory duties (1-3 direct reports)