Biostatistics Manager
Core
Provide statistical expertise, author/review study documents, and perform data analyses for clinical studies across the drug development lifecycle.
Role type
Senior individual contributor biostatistician (clinical trials)
Builds
Clinical Study Reports (CSRs), tables, figures, listings, and submission data files for drug development
Domain
Biotechnology / Clinical Drug Development
Required skills
Statistical methods, clinical trial methodology, data analysis, protocol design, regulatory compliance, cross-functional collaboration, quality control, process improvement
Preferred skills
Machine learning, real-world data analytics, electronic health record analysis, clinical trial simulation, life-cycle drug development experience
Technologies
AI tools for streamlining statistical work
Responsibilities
Author and review statistical documents (KDE, protocols, SAP, TFLs), perform risk assessments, manage self and resources, review external supplier deliverables, maintain TMF statistics sections, assist in AI technology implementation
Seniority
Mid-level, hands-on IC
