Lead Medical Affairs Specialist, Real World Evidence & Biostatistics (Hybrid - San Diego, CA)

About the position 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.

Requirements

• 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.
• 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.
• 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) Nice-to-haves
• Familiarity with diabetes technologies (e.g., insulin pumps, CGMs) is a plus.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs Apply tot his job

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