Associate Director, Biostatistics
Core
Lead statistical activities for clinical trials, including design, protocol writing, analysis planning, and data interpretation for drug candidates.
Role type
Senior IC biostatistician (clinical development)
Builds
Clinical study reports, regulatory documents (DSURs, Briefing Documents), and scientific articles
Domain
Pharmaceutical biotechnology (RNAi therapeutics)
Required skills
SAS programming, clinical trial design, statistical analysis planning, regulatory document writing, CRO management
Preferred skills
R programming, CDISC standards (SDTM, ADaM, CDASH), adaptive trial design, Phase 3 clinical development experience, FDA interaction 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; Write ADS and ad hoc analysis specifications; Contribute to clinical study reports and regulatory documents; Represent the company in meetings with regulators and Key Opinion Leaders; Consult with R&D colleagues on statistical questions; Manage CRO statistical and programming support.
Seniority
Senior, hands-on IC