RWE Senior Epidemiologist/Senior Observational Research Scientist

About This Role

Lead and design epidemiological and observational research projects to generate real-world evidence for internal and external decision-making within the biopharmaceutical industry.

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 (e.g., responses to regulatory authorities, rapid analyses of safety queries)
• 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, white papers
• Support the effective communication of study/analysis results to support internal and external decisions
• Coauthor abstracts and manuscripts for external dissemination of methodologic study results
• Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities

Requirements

• PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post-doctoral experience (or Master's with 7-9 years experience)
• Deep understanding of observational research methods and experience to support the design and conduct of observational research
• Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases
• Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations in a matrix environment
• Ability to manage priorities and performance targets

Qualifications

• PhD in Epidemiology, Biostatistics, Psychometrics, or related field OR Master's degree in epidemiology, biostatistics, bioinformatics, or relevant scientific field
• Minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment (or 7-9 years with Master's degree)

Nice to Have

• Record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation
• Experience in leading drug development project for 2+ years for therapeutic area of assignment

Benefits