Associate Director, Biostatistics
Core
Lead statistical activities for clinical trials, including trial design, protocol authoring, analysis planning, and data interpretation for drug candidates.
Role type
Associate Director, Biostatistics
Builds
Clinical development plans and regulatory submissions for RNAi therapeutics
Domain
Biopharmaceuticals / RNAi therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming, clinical trial design, statistical analysis plan creation, regulatory document authoring, CRO management
Preferred skills
R programming, adaptive trial design, CDISC standards (SDTM, ADaM, CDASH), Phase 3 clinical development experience, lead statistician experience
Technologies
SAS, R, EAST
Responsibilities
Represent biostatistics at cross-functional meetings to drive clinical development; Collaborate with Clinical Development and Regulatory teams to design clinical trials; Write statistical sections of clinical trial protocols; Prepare statistical analysis plans; Collaborate on eCRF design; Provide statistical guidance on ongoing trials; Collaborate with Statistical Programmers on data analysis; Write ADS and ad hoc analysis specifications; Contribute to clinical study reports and regulatory documents; Represent company in meetings with regulators and KOLs; Contribute to scientific articles; Manage CRO statistical and programming support
Seniority
Senior, hands-on IC with management responsibilities
