Director, Epidemiology RWE - Pharma

Director, Epidemiology RWE - Pharma Co Job Responsibilities

• Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE.
• Lead, design, and manage epidemiological, biomarker, and/or data science projects.
• Lead, plan, design, and conduct analyses for internal and external decision making, such as responses to regulatory authorities and rapid analyses of safety queries.
• Lead the identification of fit‑for‑purpose data for the timely execution of the RWE strategy.
• Construct cohorts using real‑world data sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedure codes, and plan validation studies as needed.
• Contribute to the communication of observational research results and methods, including development of relevant sections of regulatory documents, reports, publications, and white papers.
• Support effective communication of study/analysis results to support internal and external decisions.
• Coauthor abstracts and manuscripts for external dissemination of methodological study results.
• Develop processes and training aimed at increasing the efficiency, quality, and impact of functional activities.
• Support the effective communication of study/analysis results to internal and external stakeholders.
• Coauthor abstracts and manuscripts for external dissemination of methodological study results.
• Contribute to the development of processes and training to increase the efficiency, quality, and impact of functional activities.

Sr Epi - Inflam‑Liver Group. Hybrid trial adding controls to placebo group. CDisc Reqs, Pharma Co Epi.

• Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE.
• Lead, design, and manage epidemiological, biomarker and/or data science projects.
• Lead, plan, design, and conduct analyses for internal and external decision making.
• Lead the identification of fit‑for‑purpose data for the timely execution of the RWE strategy.
• Construct cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed.
• Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, and white papers.
• Support the effective communication of study/analysis results to support internal and external decisions.
• Coauthor abstracts and manuscripts for external dissemination of methodological study results.
• Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities.
• Technical Expertise:
  • Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes.
  • Ability to design studies independently, translating research questions into study design.
• Subject Matter Expertise:
  • Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (e.g., claims, EHR, PRO/COA, registry data) for methodological research questions.

• PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post‑doctoral experience.
• Master's degree in epidemiology, biostatistics, bioinformatics, or relevant scientific field, plus 7‑9 years of experience in lieu of PhD may be acceptable.
• Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development.
• Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases.
• Record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
• Demonstrated ability to function with an increasing level of autonomy and to develop productive cross‑functional collaborations in a matrix environment.
• Ability to manage…