Epidemiology Lead

Role Summary

Epidemiology Lead.

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‚Äôs in Epidemiology, Public Health, Biostatistics, or related field acceptable).
• 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‚Äô experience of proven track record in designing and executing epidemiological studies across product lifecycle required.
• Minimum of 8 years‚Äô experience in managing large datasets, conducting complex data analyses, and extracting meaningful insights.
• 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.
• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required.
• Proficiency in English (speaking, reading, writing) required.