Senior Manager, Biostatistics - Early Phase
About The Position
This position is to serve as a study level statistician for oncology studies, and to coordinate activities with other functional groups to ensure timely deliverables. Represent biostatistics on study/project teams. Provide statistical expertise for design, analysis and reporting of clinical studies. Collaborate with various functions on study design and planning, protocol development, statistical methodology and analysis. Develop statistical analysis plans and analysis specifications. Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications. Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection. Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation. Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.
Requirements
- Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 3 years (for Ph.D.) and 6 years (for M.S.) of experience in biotech/pharma industry as a statistician.
- Hands-on experience in design and analysis of oncology trials is a must.
- Ability to apply statistical knowledge to solve real-world problems and acquire new knowledge in advanced statistical methods (e.g., Bayesian methods, predictive modeling etc.)
- Excellent verbal and written communication skills are required.
- Good interpersonal and project management skills are essential.
- Proficiency in SAS and/or R.
Responsibilities
- Serve as a study level statistician for oncology studies
- Coordinate activities with other functional groups to ensure timely deliverables
- Represent biostatistics on study/project teams
- Provide statistical expertise for design, analysis and reporting of clinical studies
- Collaborate with various functions on study design and planning, protocol development, statistical methodology and analysis
- Develop statistical analysis plans and analysis specifications
- Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications
- Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection
- Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation
- Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
