Job Description
Job Description: • Lead a team of biostatisticians, managing performance, resource planning, prioritization and timelines • Direct statistical design, analysis, and reporting for feasibility, pivotal, post-market, and RWE clinical studies • Provide strategic guidance on study design, protocol development, CRF review, endpoint selection, statistical analysis methods, and definition of acceptance criteria • Lead or oversee the development and execution of Statistical Analysis Plans (SAPs), ensuring data integrity and analytical rigor • Guide statistical contributions to regulatory submissions (e.g., IDEs, PMAs, 510(k)s) and represent Biostatistics in interactions with regulatory agencies • Support scientific publications through data analysis and interpretation for abstracts, posters, and manuscripts • Collaborate with cross-functional teams including Data Management, Clinical, R&D, Regulatory Affairs, and Medical Affairs • Identify and implement innovative statistical methodologies to address complex study challenges • Communicate project status, risks, and scope changes to leadership Requirements: • M.S.
in Biostatistics, Statistics, Data Science, or related field with 10+ years of experience; Ph.D. preferred • Minimum 2 years of team management or supervisory experience • Industry experience in pharmaceutical, medical devices, or biotechnology highly desirable • Experience managing biostatistics teams and operations • Proficient in statistical methods and programming; expertise in advanced techniques preferred • Strong SAS programming skills; R experience is a plus. Benefits: • A full and comprehensive benefits program • Growth opportunities on a global scale • Access to career development through in-house learning programs and/or qualified tuition reimbursement • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
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