Associate Director, Biostatistics

Role: Associate Director, Biostatistics, leading statistical activities for clinical trials in a biopharma setting, supporting RNAi therapeutic development. Responsibilities: contribute to trial design, author protocols and analysis plans, review and interpret data, collaborate on eCRF design, guide ongoing trial conduct, prepare regulatory documents, and represent the company in interactions with regulators and key stakeholders. Manage CRO support and contribute to scientific publications. Qualifications: Ph.D. in Biostatistics/Statistics with ≥7 years or MS with ≥10 years pharma experience, proficient in SAS and familiar with R, EAST, CDISC standards, and GCP compliance. Preferred: experience in Phase 3 development, regulatory interactions, adaptive trial design, and biologic or RNAi areas. High-Value: biopharma (RNAi therapeutics), clinical development through Phase 3, regulatory submissions, statistical programming expertise, and stakeholder engagement. Work setup: not specified.