Manager Biostatistics (Study Statistician and/or Study Lead Statistician)
Core
Lead statistical analysis and study design for clinical trials in drug development, ensuring regulatory compliance and data quality.
Role type
Manager, Biostatistics (Study Statistician/Lead)
Builds
Clinical Study Reports (CSRs), statistical analysis plans, tables, figures, listings, and submission data files for life-cycle drug development.
Domain
Biotechnology / Clinical Drug Development
Required skills
Statistical analysis, study design, regulatory standards (CFDA), cross-functional collaboration, risk assessment, process improvement, AI/ML integration
Preferred skills
Machine learning, real-world data analytics, electronic health record analysis, clinical trial simulation
Technologies
AI tools for statistical workflow, electronic health record systems
Responsibilities
Review and quality control of study design documents and protocols; execute clinical trials according to protocol; oversee statistical contributions to analysis plans and reports; collaborate on TFLs and clinical publications; manage self and resources; review external supplier deliverables; assist in AI technology implementation
Seniority
Manager, hands-on IC with team leadership
