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 the team and providing expert statistical support for internally sponsored , real-world evidence (RWE), and external clinical studies . The position requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry . Th e position require s strong leadership skills, the ability to navigate complex 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 addition, this role will demonstrate strong communication /presentation skills and will support senior leaders in data analytics . Responsibilities • Lead and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians. • Develop and implement statistical methodologies for sample size calculations and power analysis. • Generation of randomization schedules. • Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies . • M anage various datasets, determine summary statistics, conduct hypotheses testing, estimate statistical models, report formats and other analysis considerations. • Design and conduct complex statistical analyses for clinical studies , RWE, and other data needs . • Prepare statistical analysis plans including development of well-presented mock-up displays for tables, listings, and figures • R eview and provide 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 projects / ad-hoc reporting as needed . Benefits • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Apply tot his job