Associate Director, Biostatistics

Role: Associate Director of Biostatistics supporting clinical trial design, analysis, and regulatory submissions in a biopharma setting. Responsibilities include collaborating on trial designs across development phases, authoring statistical sections of protocols, preparing analysis plans, guiding ongoing trial conduct, and contributing to regulatory documents and scientific publications. The role involves cross-functional interaction with Clinical Development, Regulatory, Data Management, and external partners, with CRO management responsibilities. Qualifications: Ph.D. in Biostatistics/Statistics (7+ years pharma experience) or MS (10+ years); expertise in SAS, understanding of biology and RNAi therapeutics preferred. Additional skills in R, EAST, CDISC standards, and regulatory interactions are desirable. Experience progressing compounds through Phase 3 and NDA submissions, with familiarity in adaptive trial design, GCP, and international regulatory engagement highly valued. The position may include interactions with U.S. FDA and international agencies, supporting the development of RNAi therapeutics. Work setup and travel specifics are not specified.