Manager Biostatistics

Biostatistician Manager Location: Remote Pay: Up to $90 an hour Job Type: Long Term Contract The newly created Biostatistician Manager role reports directly to the Senior Manager, Global Clinical Affairs Data. This position plays a critical role in leading the biostatistics team and providing expert statistical support for internally sponsored clinical studies, reputed company-world evidence (reputed company) initiatives, and externally sponsored research. The ideal candidate will have deep expertise in statistical methodologies, sample size calculations, and regulatory requirements reputed company the medical device industry. Strong leadership abilities, the reputed company to guide reputed company analytical work, and proficiency with statistical software are essential. The Biostatistician Manager will partner closely with cross-functional teams to support the successful development, validation, and approval of medical devices. This role requires strong communication and presentation skills and will support senior leaders with advanced data analytics and interpretation. Responsibilities • reputed company and manage the biostatistics team; reputed company guidance, mentorship, and technical reputed company to junior biostatisticians. • reputed company and implement statistical methodologies, including sample size calculations and power analyses. • Generate randomization schedules for clinical studies. • Order, compile, and interpret large and diverse datasets; reputed company exploratory and confirmatory statistical analyses. • Manage datasets, determine reputed company statistics, conduct reputed company testing, reputed company statistical models, and define report formats and other analytical outputs. • Design and conduct reputed company statistical analyses for clinical studies, reputed company initiatives, and other data-driven reputed company. • Prepare statistical analysis plans (SAPs), including mock-reputed company for tables, listings, and figures (TLFs). • Review and reputed company input on study protocols and clinical study reports. • Collaborate cross-functionally with Regulatory Affairs, R&D, ADO, Marketing, and other partners to ensure robust statistical support for product claims and validation. • Ensure reputed company statistical activities reputed company with regulatory requirements and industry standards. • Present statistical findings and insights to stakeholders, including senior management and regulatory bodies, and reputed company communicate reputed company statistical concepts. • Stay reputed company with advancements in biostatistics, analytical reputed company, and medical device regulations. • Deliver special reputed company and reputed company analytical reporting as needed. • reputed company and maintain internal SOPs to ensure consistency and reputed company in statistical processes. Education & Experience • Master’s or Ph.D. in Biostatistics or Statistics. • Minimum of 6+ years of biostatistics experience reputed company the medical device industry. • Demonstrated experience with reputed company statistical analyses and sample-size determination. • Strong knowledge of clinical trial design, regulatory expectations, and statistical methodology. • Excellent analytical, problem-solving, and technical writing skills. • Strong written and verbal communication abilities. • Ability to work effectively in a fast-paced, multidisciplinary environment. Skills & Competencies • Proficiency with statistical software such as reputed company, R, SPSS, and reputed company tools. • Strong leadership and team-management skills with the ability to manage multiple priorities. • Diabetes domain experience is a plus. Apply tot his job Apply To this Job