Senior Manager /Associate Director, Biostatistics

Role: Senior Manager/Associate Director, Biostatistics, leading statistical activities in Scholar Rock's clinical development programs targeting neuromuscular diseases, from Phase 1 through Phase 3. Responsibilities: designing trials, developing statistical analysis plans, conducting modeling and simulations, analyzing data, authoring regulatory documents, and supporting regulatory interactions. Also overseeing outsourced statistical activities and contributing to publications. Requirements: PhD in statistics, biostatistics, or related field; 2+ years (Senior Manager) or 4+ years (Associate Director) drug development experience; proficiency in SAS and R; strong analytical, decision-making, and communication skills; ability to manage multiple studies and external vendors; knowledge of FDA/ICH regulations; up-to-date with clinical trial design methodologies, especially in rare diseases. Preferred: experience with NDA/BLA filings and managing CROs. High-Value: focus on biologics/modality targeting myostatin, early to late-stage clinical trials, regulatory submission support, and global collaboration. Work setup: not specified; up to 20% travel may be required.