Role Summary
The Senior Manager, RWE/Epi Scientist, position within Medical Evidence Development (MED) Real-World Evidence & Epidemiology (RWE/Epi) provides an opportunity for a collaborative epidemiologist to support real-world evidence and epidemiologic studies as part of Medical strategy across the entire drug development process. The candidate will be responsible for synthesizing the literature and contributing to the design, conduct and reporting of global epidemiologic research studies on Pfizer I&I products. The Senior Manager will also be accountable for the quality, timeliness, and efficiency of all RWE/Epi deliverables in assigned product/disease area, and maintain an internal network of Pfizer stakeholders to cultivate innovation, cross-functional collaboration, and identify new opportunities for RWE/Epi to increase the value of Pfizer assets. The candidate will develop external partnerships to leverage data resources and collaboration on high priority global studies. Responsibilities include authoring and reviewing study protocols, reports, and presentations, as well as communication in writing and presentations to internal stakeholders, regulatory authorities, and medical professionals. The candidate will also be responsible for non-study deliverables such as RWE insights, epidemiology literature reviews, regulatory responses, and department initiatives.
Responsibilities
- Authoring and reviewing study protocols, reports, and presentations; communicating in writing and presentations to internal stakeholders, regulatory authorities, and medical professionals
- Authoring and reviewing non-study deliverables such as RWE insights, epidemiology literature reviews, regulatory responses, and department initiatives
- Capabilities include identifying, designing and supporting or leading 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 for addressing questions of interest, recognizing design options and data source strengths and limitations
- 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
- Assure the highest 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 and other metrics
Qualifications
- Required: PhD in Epidemiology, Statistics/Biostatistics, Health Outcomes Research, Quantitative Methods, Public Health, Health Economics, or other biological sciences 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 Masterβs degree and at least 5 years of experience in the pharmaceutical, academic and/or medical environment, at least 1 year in the pharmaceutical industry
- Required: Demonstrated strong quantitative skills and methods expertise to generate rapid insights from real-world/observational data
- 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 analysis 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: Knowledgeable of the external regulatory environment for real-world evidence and maintains awareness of scientific developments in epidemiology, medicine, and technology (e.g., artificial intelligence)
- Preferred: Proficiency in rapid real-world data analytical platforms
- Preferred: Experience working with real-world data (RWD) including EMR, claims, and surveys
- Preferred: Excellent problem-solving and decision-making abilities
- Preferred: Ability to influence and collaborate with senior management and stakeholders
- Preferred: Strong project management skills with the ability to handle multiple projects simultaneously
Skills
- Real-world evidence study design and execution
- Data resource assessment and methodological design
- Regulatory submission support and communication
- Scientific writing and presentation
- Data visualization and interpretation
- Cross-functional collaboration in a matrixed environment
Education
- PhD in Epidemiology, Statistics/Biostatistics, Health Outcomes Research, Quantitative Methods, Public Health, Health Economics, or related field with substantial quantitative component; or MPH or equivalent with substantial relevant experience
Additional Requirements
- Lifting, sitting, standing, walking, bending; ability to perform mathematical calculations and complex data analysis
- Work Location: Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week or more as needed