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Lead Clinical Statistician
3 weeks ago
The Senior Biostatistician is a key professional in the planning, execution and interpretation of statistical analyses across development programs. Their responsibilities include leading, developing, implementing and overseeing statistical strategies and deliverables in support of clinical trials.
Essential Functions
- Biostatistics leader for assigned studies and projects
- Study design discussions, protocol development, endpoint definition and sample size estimation
- Author and review Statistical Analysis Plans (SAPs)
- Execution of statistical analyses per SAP
- Statistical leadership in vendor oversight
- Regular project status updates to management
- Statistical input and review for clinical study reports and publications
- Quality control of statistical outputs
- Regulatory interactions on statistical issues
- Master's degree or PhD in Biostatistics, Statistics or related quantitative field
- Minimum 8 years of experience in clinical trial biostatistics
- Proficiency in statistical programming in SAS and knowledge of R
- Solid knowledge of statistical methodologies and clinical trial designs
- Experience with regulatory support and interaction
- Proven ability to manage multiple studies concurrently
- Excellent verbal and written communication skills