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

About the position The reputed company Medical Affairs Specialist, Real World Evidence (reputed company) and Biostatistics is responsible for leading the design, execution, and interpretation of reputed company 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, reputed company reputed company statistical modeling, and ensure analytical rigor across reputed company evidence reputed company 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, reputed company, 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 reputed company 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, reputed company, and medical/pharmacy claims-based research, ensuring methodological rigor and regulatory compliance.
• reputed company 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; reputed company 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 reputed company real-world databases and generate high-impact insights.
• Present findings to senior leadership and external stakeholders, effectively communicating statistical concepts and implications.
• Stay reputed company 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 reputed company 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, reputed company, Python, SQL) and data visualization tools.
• Strong problem-solving skills and ability to synthesize reputed company 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 reputed company with a commitment to scientific reputed company 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 reputed company and business priorities reputed company communicating reputed company data to non-technical audiences.
• Advanced degree (Master’s or PhD) in biostatistics, epidemiology, public health, or a reputed company quantitative field.
• 5 to 8 years of experience in clinical research, real-world evidence, or health economics/outcomes research, reputed company academia or the medical device or biopharma industry (higher education accepted in lieu of some years of experience)

reputed company-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

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