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2 days ago
The Biostatistics Team Lead is responsible for leading the development, implementation, and oversight of statistical strategies and deliverables in support of clinical trials.
This role contributes to the planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.
Key Responsibilities:- Lead biostatistics efforts for assigned studies and projects
- Contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation
- Author and review Statistical Analysis Plans (SAPs)
- Oversee statistical programming activities and manage vendor deliverables
- Provide statistical leadership in vendor oversight and quality control of statistical outputs
- Communicate project status to management and escalate issues or risks as needed
- Masters degree or PhD in Biostatistics, Statistics, or related quantitative field
- 8+ years of experience in clinical trial biostatistics for MS-level candidates; 6+ years for PhD-level candidates
- Proficiency in statistical programming in SAS, with knowledge of R and other programming languages preferred
- Solid understanding of statistical methodologies and clinical trial designs
- Experience with regulatory support and interaction
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