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.
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.
Applicant Tracking System Keywords
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