pliance 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.
About Your Skills & Experience
- Masters in Epidemiology, Public Health, Biostatistics, or related field. Ph.D. is preferred.
- Proven track record in designing and executing epidemiological studies across product lifecycle.