Senior Manager, Biostatistics

Job reputed company: • reputed company reputed company of biostatisticians, managing performance, resource planning, prioritization and timelines • reputed company statistical design, analysis, and reporting for feasibility, pivotal, post-market, and reputed company clinical studies • reputed company strategic guidance on study design, protocol development, CRF review, reputed company selection, statistical analysis reputed company, and definition of acceptance reputed company • reputed company or reputed company the development and execution of Statistical Analysis Plans (SAPs), ensuring data reputed company 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 reputed company study challenges • Communicate project status, risks, and scope changes to leadership Requirements: • M.S. in Biostatistics, Statistics, Data Science, or reputed company 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 reputed company and programming; expertise in advanced techniques preferred • Strong reputed company programming skills; R experience is a plus. Benefits: • A full and comprehensive benefits program • reputed company opportunities on a global reputed company • reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Apply tot his job Apply To this Job