Lead Biostatistician, Biostatistics, R&D
Job in
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listed on 2026-07-21
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-21
Job specializations:
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Research/Development
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IT/Tech
Information Security & Data Protection, Data Analyst
Job Description & How to Apply Below
Responsibilities
- Provide scientific and strategic biostatistics leadership for oncology portfolio
- Contribute to clinical development plans and study designs
- Serve as the lead statistician for development programs
- Ensure delivery of biostatistics outputs in line with timelines and quality expectations
- Provide statistical leadership for regulatory submissions
- Define and standardize statistical methodologies
- Lead adoption of AI-enabled analytics and automation
- PhD or MSc in Statistics, Biostatistics, or a related field (PhD preferred)
- 10+ years of experience in clinical drug development, oncology preferred
- Extensive regulatory experience (FDA, EMA, ICH)
- Deep expertise in oncology
- Strong command of advanced statistical approaches (e.g. Bayesian and adaptive designs)
- Excellent leadership and collaboration skills
- Understanding of AI-assisted statistical workflows
Demonstrates expertise in biostatistics leadership within oncology, with a strong focus on regulatory submissions and advanced statistical methodologies. Proven ability to lead clinical development plans and adopt AI-enabled analytics for enhanced statistical workflows.
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