• Job Description

  Req#: REQ-2025-11328

  Job Title : Biostatistician Manager, Clinical Affairs

  Department: Clinical

  FLSA Status: Exemp t
  

  Position Overview:

  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 .

  NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days). #LI-Hybrid

  Additional Information:

  Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $122,700.00 - $184,050.00 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.

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• About the company

  Automate injectable drug delivery with the customizable OmniPod by Insulet. See how it's improving lives with better adherence and seamless delivery.

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