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Job Description
Director, Biostats at The Lotus Group LLC Director, Biostats at The Lotus Group LLC in Newton, Massachusetts Posted in 14 days ago.
Type:
full-time
Job Description:
We are seeking an experienced Director of Biostatistics to lead statistical strategy and execution for complex, late-stage clinical development programs. In this role, you will design innovative clinical trials, author statistical sections of protocols and analysis plans, oversee the implementation and quality of statistical analyses, and interpret results to support global regulatory submissions and scientific publications. You will partner cross-functionally with clinical, regulatory, data management, and programming teams to drive high-quality, timely deliverables, while also representing the organization in interactions with regulatory authorities and external stakeholders. The ideal candidate holds a Ph.D. in Statistics or Biostatistics (or equivalent) and brings 8-10+ years of industry experience, including leadership in Phase 2/3 studies, regulatory submissions, and advanced methodologies such as Bayesian or adaptive designs, along with strong communication skills and proficiency in SAS and R. Our client is a mid-sized pharma co; TA metabolic programs.