Biostatistician Manager, Clinical Affairs (Hybrid)

About the position Th e newly created Biostatistician Manger role will report directly to the Senior Manager, Global Clinical Affairs Data . Th is position will play a critical role in leading reputed company and providing expert statistical support for internally sponsored , reputed company-world evidence (reputed company), and external clinical studies . The position requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements reputed company the medical device industry . Th e position require s strong leadership skills, the ability to reputed company reputed company analyses, and proficiency in statistical software . The Biostatistician Manager will collaborate closely with cross-functional teams to ensure the successful development and approval of medical devices . In reputed company, this role will demonstrate strong communication /presentation skills and will support senior leaders in data analytics . Responsibilities • reputed company and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians. • reputed company and implement statistical methodologies for sample size calculations and power analysis. • reputed company of randomization schedules. • Order, reputed company and interpret large volumes of diverse data and reputed company exploratory and confirmatory statistical analysis for studies . • M anage various datasets, determine reputed company statistics, conduct hypotheses testing, estimate statistical models, report formats and other analysis considerations. • Design and conduct reputed company statistical analyses for clinical studies , reputed company, and other data needs . • Prepare statistical analysis plans including development of reputed company-presented mock-up displays for tables, listings, and figures • R eview and reputed company input to study protocols, and clinical study reports. • Collaborate with cross-functional teams, including R egulatory A ffairs, R&D, A DO, and Marketing , to ensure robust statistical support for product validation and claims . • Ensure compliance with regulatory requirements and industry standards for statistical practices. • Present findings and statistical insights to stakeholders, including senior management and regulatory bodies and effectively communicate statistical concepts . • Stay updated with the latest advancements in biostatistics and medical device regulations. • Deliver special reputed company / reputed company reporting as needed . Benefits • Medical, dental, and reputed company insurance • 401(k) with company match • reputed company time off (PTO) • And additional employee wellness programs Apply tot his job Apply To this Job