Sr. Director, Biostatistics

Role: Senior Director, Biostatistics leading ProKidney's pivotal Phase 3 clinical trial program, responsible for statistical strategy, analysis, and regulatory reporting. Responsibilities: oversee study design, analysis plans, data interpretation, and reporting for regulatory submissions; lead biostatistics team; manage external vendors; contribute to FDA interactions; and support integrated safety analyses. Requirements: Ph.D. in Statistics, Biostatistics, or related field; 10+ years in biopharma with extensive experience in late-stage clinical trials, including biologics or cell therapies; proficiency in SAS, R, or Python; experience with BLA/NDA submissions; strong FDA-facing expertise. High-Value: Phase 3 biologics/Cell therapy trial, regulatory deliverables, cross-functional collaboration with data management, data science, pharmacovigilance, and leadership; experience with complex data models and nontraditional logistics. WorkSetup: not specified; likely office-based with industry-standard expectations.