Epidemiology Lead

Role Summary

The Epidemiology Lead will drive evidence generation to support clinical development, regulatory filings, health technology assessments, and post-marketing safety commitments. The role leads the design and execution of epidemiological studies to quantify disease burden, treatment patterns, and patient outcomes, while ensuring scientific rigor, data quality, and regulatory/ethical compliance. In addition, the role provides lifecycle support, collaborates across functions, and translates findings into actionable insights for stakeholders.

Responsibilities

• Epidemiology & Evidence Generation
  • Generate evidence to support clinical development, regulatory filings, health technology assessments, and post-marketing safety commitments
  • Lead the design and execution of epidemiological studies to quantify disease burden, treatment patterns, and patient outcomes in collaboration with the Outcomes Research (OR) team
  • Develop study protocols, statistical analysis plans, and methodologies for observational and real-world studies
  • Ensure scientific rigor, data quality, and compliance with regulatory and ethical standards
• Lifecycle Support
  • Provide epidemiological input during early development for target product profiles and clinical trial design
  • Post-launch, monitor product performance, safety, and effectiveness through observational studies and registries
• Cross-Functional Collaboration
  • Partner with clinical development, global medical affairs, regulatory, market access, and commercial teams to align epidemiology strategies with asset priorities
  • Engage external stakeholders including academic institutions, healthcare providers, and regulatory agencies
  • Collaborate with patient advocacy groups to incorporate patient perspectives into study design and evidence generation
• Technical Expertise
  • Apply advanced epidemiological methods and statistical techniques to analyze large and complex datasets
  • Utilize diverse real-world data sources (EHRs, claims, registries, patient-reported outcomes) for evidence generation
  • Stay abreast of emerging methodologies, technologies, and regulatory guidance in epidemiology and real-world evidence
• Communication & Reporting
  • Translate complex epidemiological findings into actionable insights for internal and external stakeholders
  • Prepare and present evidence packages for regulatory authorities, HTA bodies, and scientific forums
  • Develop publication strategies and lead dissemination of study results in peer-reviewed journals and conferences
• Operational Excellence
  • Ensure adherence to ethical standards, data privacy, and compliance requirements globally
  • Manage budgets, timelines, and resources for epidemiology projects
  • Drive continuous improvement and innovation in epidemiology processes and tools

Qualifications

• Education: Ph.D. strongly preferred (Master’s in Epidemiology, Public Health, Biostatistics, or related field acceptable)
• Skills: Expertise in epidemiological methods and statistical software (e.g., SAS, R)
• Strong communication and stakeholder engagement skills
• Strategic thinking and ability to influence decision-making
• Minimum of 8 years’ experience designing and executing epidemiological studies across the product lifecycle
• Minimum of 8 years’ experience managing large datasets, conducting complex data analyses, and extracting meaningful insights (combination of experience and/or education considered)
• Substantial experience in the pharmaceutical or healthcare industry; ability to develop and execute strategic plans aligned with business objectives
• Proficiency in statistical software packages
• Certification in Healthcare Data Analytics and Management preferred
• Certification in Health Economics and Outcomes Research preferred

Education

• Ph.D. strongly preferred; Master’s in Epidemiology, Public Health, Biostatistics, or related field acceptable

Additional Requirements

• Typically sitting at a desk or table; intermittent sitting, standing, walking or stooping
• Periodic travel is required
• Proficiency in speaking, comprehending, reading, and writing English is required