Biostatistician (Hybrid - Acton, MA)

Job Summary The Biostatistician will play a critical role in the design, analysis, and interpretation of clinical data to support product development, regulatory submissions, and publications. This position will contribute directly to the success of clinical programs, particularly those focused on diabetes-related technologies, and will collaborate cross-functionally to ensure statistical integrity and compliance with industry standards. Position Overview: The Biostatistician will play a critical role in the design, analysis, and interpretation of clinical data to support product development, regulatory submissions, and publications. This position will contribute directly to the success of clinical programs, particularly those focused on diabetes-related technologies, and will collaborate cross-functionally to ensure statistical integrity and compliance with industry standards. Responsibilities: Design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D. Develop statistical analysis plans (SAPs) and perform statistical analyses using SAS, MATLAB, and R. Provide statistical input for study protocols, case report forms (CRFs), and clinical study reports (CSRs). Ensure statistical deliverables meet regulatory requirements and industry standards (FDA, EMA, ICH-GCP, ISO). Provide data summaries to support data integrity and data review during ongoing studies. Support regulatory submissions with statistical summaries and responses to agency queries. Contribute to scientific publications and presentations of clinical data. Stay current with statistical methodologies and regulatory guidelines relevant to medical devices and diabetes research. Performs other duties as required. Education and Experience: Minimum Requirements: Bachelor's in Biostatistics, Statistics, or a related field. Minimum of 5 years of experience in biostatistics within the medical device or pharmaceutical industry. Proficiency in statistical tools, such as SAS, MATLAB, and R for programming and data analysis. Strong understanding of clinical trial design, data management, and regulatory requirements. Preferred Skills and Competencies: Familiarity with real-world evidence (RWE) and health economics outcomes research (HEOR). Experience with adaptive trial designs or Bayesian methods. Experience with diabetes-related clinical studies. Knowledge of electronic data capture (EDC) systems and clinical databases. Excellent communication and collaboration skills. Strong analytical and problem-solving abilities. Physical Requirements (if applicable): Primarily sedentary role with standard office-based activities. Occasional travel may be required for meetings, conferences, or team meetings. NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $104,100.00 - $156,150.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. ( Know Your Rights )