Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview:

The Lead Medical Affairs Specialist, Real World Evidence (RWE) and Biostatistics is responsible for leading the design, execution, and interpretation of RWE studies supporting Omnipod products. This role is highly technical and centers on applying advanced statistical methodologies to analyze clinical, claims, and real-world datasets. The incumbent will contribute to the development of study protocols and statistical analysis plans, perform complex statistical modeling, and ensure analytical rigor across all evidence generation activities. Collaboration with internal teams such as Data Science, Regulatory Affairs, and R& D is essential to ensure alignment with regulatory standards and scientific best practices. Success in this role requires deep expertise in biostatistics, proficiency in statistical programming tools (e.g., R, SAS, Python, SQL), and a strong understanding of observational research methods. The ability to manage large datasets, conduct exploratory and confirmatory analyses, and communicate technical findings clearly is critical.

Responsibilities:

• Execute the global RWE strategy supporting Insulet's product portfolio and product development activities, supporting product lifecycle management and innovation initiatives
• Design and conduct advanced statistical analyses for clinical studies, RWE, and medical/pharmacy claims-based research, ensuring methodological rigor and regulatory compliance.
• Develop and review study documentation, including protocols, statistical analysis plans (SAPs), and mock-up displays for tables, listings, and figures.
• Manage and analyze large, diverse datasets; perform exploratory and confirmatory analyses, hypothesis testing, and statistical modeling.
• Review and provide input to study protocols and clinical study reports.
• Collaborate with internal teams (Regulatory Affairs, R& D, Market Access, Marketing) to ensure robust statistical support for product validation and claims substantiation.
• Partner with data science teams to leverage real-world databases and generate high-impact insights.
• Present findings to senior leadership and external stakeholders, effectively communicating statistical concepts and implications.
• Stay current with advancements in biostatistics, epidemiology, and medical device regulations.
• Contribute to the development and maintenance of SOPs to ensure consistency and quality in statistical practices.
• Ensure compliance with regulatory requirements and industry standards for statistical practices.

Key Decision Rights

• Study Design & Methodology: Decide on appropriate statistical approaches and data sources for RWE and observational studies.
• Statistical Analysis Plans (SAPs): Lead the development and approval of SAPs, ensuring alignment with study objectives and regulatory standards.
• Data Interpretation: Make informed decisions on the interpretation of statistical outputs and their relevance to clinical and regulatory contexts.
• Protocol & Report Review: Provide expert input on statistical sections of study protocols and reports to ensure analytical integrity.

Required Skills and Competencies

• Proven experience leading complex research projects in industry, academia, or CRO settings.
• Deep understanding of real-world data sources (e.g., medical/pharmacy claims, electronic medical records, registries) and their application in observational research, with hands-on experience analyzing large U.S. claims datasets (commercial, Medicare, Medicaid).
• Expertise in epidemiologic methods and statistical modeling.
• Proficiency in statistical software (e.g., R, SAS, Python, SQL) and data visualization tools.
• Strong problem-solving skills and ability to synthesize complex data into strategic insights.
• Familiarity with diabetes technologies (e.g., insulin pumps, CGMs) is a plus.

Required Leadership/Interpersonal Skills & Behaviors

• Demonstrated ability to work independently and manage multiple high-impact projects.
• Strong communication and presentation skills, with the ability to influence cross-functional teams and senior stakeholders.
• Collaborative, proactive, and adaptable mindset with a commitment to scientific integrity and excellence.
• Ability to mentor junior team members or cross-functional colleagues on statistical concepts, study design, and data interpretation, fostering a culture of analytical excellence.
• Strong stakeholder management skills, with the ability to balance scientific integrity and business priorities when communicating complex data to non-technical audiences.

Education and Experience:

• Advanced degree (Master's or PhD) in biostatistics, epidemiology, public health, or a related quantitative field.
• 5 to 8 years of experience in clinical research, real-world evidence, or health economics/outcomes research, within academia or the medical device or biopharma industry (higher education accepted in lieu of some years of experience)

Additional Information:

• Hybrid role based in San Diego
• Travel up to 15%, domestic and international, based on business needs.

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 $144, 500.00 - $216, 800.00 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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