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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