Associate Director, Biostatistics
Core
Lead statistical activities for clinical trials, including trial design, protocol writing, analysis planning, and data interpretation for drug candidates.
Role type
Associate Director, Biostatistics (Senior IC with management)
Builds
Clinical study reports, regulatory documents, and statistical analysis plans for drug candidates.
Domain
Pharmaceutical biostatistics / Clinical development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming, statistical analysis, clinical trial design, regulatory document writing, cross-functional collaboration, CRO management
Preferred skills
R programming, adaptive trial design, CDISC standards (SDTM, ADaM, CDASH), Phase 3 clinical development experience, FDA interaction experience, biology/RNAi understanding
Technologies
SAS, R, EAST
Responsibilities
Design clinical trials, write statistical sections of protocols, prepare statistical analysis plans, review and interpret clinical trial data, manage CRO statistical support, contribute to clinical study reports and regulatory documents, represent the company with regulators and stakeholders, consult on statistical questions for preclinical research
Seniority
Senior, hands-on IC with management responsibilities