Associate Director, Biostatistics
Beeline Medicines · Boston
Job description
About the role
Beeline Medicines is seeking an Associate Director of Biostatistics to lead statistical strategy for its clinical development programs. You will guide study design, analysis planning, and regulatory reporting, ensuring rigorous, high‑quality statistical deliverables.
Key responsibilities
- Serve as lead statistician on one or more clinical studies from protocol design through final report.
- Develop statistical analysis plans, sample‑size and power calculations, and randomization schemes.
- Oversee production and quality control of tables, listings, and figures (TLFs) generated internally or by CROs.
- Collaborate with Clinical, Regulatory, and Data Management teams on study design and data review.
- Provide statistical input for regulatory submissions, briefing documents, and health‑authority responses.
- Review clinical study reports and publications for statistical accuracy.
Required profile
- PhD in Biostatistics, Statistics, or a closely related quantitative discipline.
- At least 5 years of biostatistics experience in pharmaceutical or biotechnology settings.
- Demonstrated ability to lead cross‑functional study teams and communicate complex quantitative concepts to diverse audiences.
Required skills
- Statistical analysis plan (SAP) development
- Sample‑size and power calculation
- Randomization scheme design
- Production and QC of tables, listings, and figures (TLFs)
- Knowledge of ICH guidelines and regulatory standards
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Published 1 month ago
Expires 5 days from now
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Beeline Medicines
Boston
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