Oncology RWE/Epi Scientist

Role Summary

The Senior Manager, RWE/Epi Scientist supports real-world evidence and epidemiologic studies across the drug development process, synthesizing the literature and contributing to the design, conduct and reporting of global epidemiologic research studies. The role is accountable for the quality, timeliness, and efficiency of RWE/Epi deliverables in the assigned product/disease area, and for maintaining cross-functional collaboration to identify opportunities for RWE/Epi value. The role also develops external partnerships to leverage data resources for high-priority global studies and includes authoring and reviewing study protocols, reports, and presentations for internal stakeholders, regulatory authorities, and medical professionals.

Responsibilities

• Identify, design and support or lead real-world evidence studies of disease epidemiology and effectiveness as part of the global cross-functional Integrated Evidence Plan.
• Maintain knowledge of internal and external data resources and identify appropriate studies, recognizing the limitations and strengths of various design options and data sources.
• Partner with Chief Medical Office colleagues to address asset team evidence needs and support global regulatory submissions to the FDA, EMA and other agencies.
• Deliver rapid insights from real-world, observational data sources.
• Develop and deliver presentations, webinars, manuscripts, scientific data packages or other communication modalities.
• Ensure high standards of quality, compliance and management of all research activities.
• Participate in RWE/Epi peer review of study protocols and study reports.
• Document all requests and track progress toward project completion, other metrics and business goals.

Qualifications

• Required: PhD in Epidemiology, Statistics/Biostatistics, Health Outcomes Research, Quantitative Methods, Public Health, Health Economics, or other biological science with substantial quantitative component and at least 1 year of relevant experience in the pharmaceutical, academic and/or medical environment; or MPH or another relevant Master’s degree with at least 5 years of experience in the pharmaceutical, academic and/or medical environment, at least 1 of which in the pharmaceutical industry.
• Required: Demonstrated strong quantitative skills and methods expertise to generate rapid insights from real-world/observational data sources.
• Required: Demonstrated strong technical writing skills and oral presentation skills with a track record of publishing in peer-reviewed journals and presenting at medical/scientific conferences.
• Required: Demonstrated ability to convert complex analyses into meaningful insights with data visualization and presentation tools; able to manipulate and analyze complex structured and unstructured data from multiple real-world evidence sources.
• Required: Ability to work under pressure with a high level of autonomy/leadership on research projects and collaborate with multiple partners in a matrixed environment.
• Required: Knowledge of the external regulatory environment for real-world evidence and awareness of scientific developments in epidemiology, medicine, and technology (e.g., artificial intelligence).

Skills

• Real-world evidence study design and execution
• Knowledge of internal and external data resources for RWE
• Regulatory submissions support for RWE/Epi
• Data visualization and communication of complex analyses
• Project coordination in a matrixed environment

Additional Requirements

• Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and complex data analysis
• This is a hybrid role requiring residence within commuting distance and on-site work average 2.5 days per week or more as needed