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, real-world evidence (RWE) initiatives, and externally sponsored research. The ideal candidate will have deep expertise in statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry. Strong leadership abilities, the capacity to guide complex 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 • Lead and manage the biostatistics team; provide guidance, mentorship, and technical oversight to junior biostatisticians. • Develop 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; perform exploratory and confirmatory statistical analyses. • Manage datasets, determine summary statistics, conduct hypothesis testing, develop statistical models, and define report formats and other analytical outputs. • Design and conduct complex statistical analyses for clinical studies, RWE initiatives, and other data-driven projects. • Prepare statistical analysis plans (SAPs), including mock-ups for tables, listings, and figures (TLFs). • Review and provide 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 all statistical activities comply with regulatory requirements and industry standards. • Present statistical findings and insights to stakeholders, including senior management and regulatory bodies, and clearly communicate complex statistical concepts. • Stay current with advancements in biostatistics, analytical methods, and medical device regulations. • Deliver special projects and ad-hoc analytical reporting as needed. • Develop and maintain internal SOPs to ensure consistency and quality in statistical processes. Education & Experience • Master’s or Ph.D. in Biostatistics or Statistics. • Minimum of 6+ years of biostatistics experience within the medical device industry. • Demonstrated experience with complex 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 SAS, R, SPSS, and related tools. • Strong leadership and team-management skills with the ability to manage multiple priorities. • Diabetes domain experience is a plus. Apply tot his job