Senior Manager, Biostatistics

Role:
Senior Manager of Biostatistics, supporting clinical development for cardiovascular therapeutics, integrating statistical expertise with machine learning to enhance data insights. Responsibilities: develop statistical analysis plans, contribute to protocol design, analyze complex datasets (including high-dimensional and observational data), and support regulatory submissions for Phase 1-4 trials. Collaborate cross-functionally with clinical teams, ensuring alignment with trial goals, safety, and efficacy assessments; translate analyses into clear reports and regulatory documents.

Requirements:
Ph.D. or M.S. in Statistics/Biostatistics; 0-2 years (Ph.D.) or 5+ years (M.S.) biotech/pharma experience; proficiency in SAS/R; strong problem-solving, strategic agility, and communication skills. Preferred: experience working with cross-functional teams, familiarity with ML/AI, ability to communicate complex concepts to non-statisticians, and understanding of drug development principles. High-Value: cardiovascular focus, early to late-stage clinical trials, statistical support for regulatory interactions, emphasis on innovative data analysis techniques including machine learning.

Work setup: not specified; likely on-site or hybrid based on location.