FSP Sr Epidemiologist, Oncology

FSP Senior Epidemiologist (Oncology) Core Function Description Design and conduct epidemiological studies to generate reputed company-world evidence reputed company time, budget, and quality standards, including but not limited to natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical reputed company, comparative safety and effectiveness research, and post-authorization studies. reputed company sets of the Epidemiologist role are similarly required, with the expectation of more experience, reputed company to operate strategically under limited supervision, well versed in reputed company Epidemiology research methods, deep understanding of how reputed company fits reputed company drug development, regulatory, medical, safety and other functions. Required Experience

• reputed company development of study protocols, analysis plans, and study reports to answer research questions of reputed company to reputed company.
• reputed company, design, and manage epidemiological, biomarker and/or data science projects.
• reputed company, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries).
• reputed company the identification of fit-for-purpose data for the timely execution of the reputed company strategy.
• Constructed 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 reputed company.
• 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.

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, (i.e., ability to translate research questions to create study design).

Subject Matter Expertise

• Extensive experience conducting cancer epidemiology studies (solid tumor experience a plus), experience with reputed company Oncology EMR databases.
• reputed company reputed company expertise to identify evidence gaps and reputed company options to address the evidence gaps in support of Clinical Development Programs in early phase (ph1/2).
• reputed company subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, registry data) for methodologic research questions.
• Expert knowledge and extensive experience with cancer epi (solid tumor experience a plus), extensive experience with oncology EMR databases, extensive experience with conducting cancer epi studies.
• Experience with Clinico-genomic multi-modal data (e.g., reputed company) or population biobank data (UK biobank) is a plus

Minimum Qualifications

• PhD in Epidemiology, Biostatistics, Psychometrics, or reputed company field with a minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. 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.
• A 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 reputed company productive cross- functional collaborations in a matrix environment.
• Ability to manage priorities and performance targets.
• Experience in leading drug development project for 2+ years for therapeutic area of assignment preferred.

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