FSP Sr Epidemiologist, Oncology

IQVIA•Sacramento, CA

13d

About The Position

The FSP Senior Epidemiologist (Oncology) is responsible for designing and conducting epidemiological studies to generate real-world evidence (RWE) within established time, budget, and quality standards. This includes studies on the natural history of disease, population characterization, assessment of treatment patterns and unmet needs, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies. The role requires extensive experience, strategic thinking with limited supervision, a strong understanding of current Epidemiology research methods, and a deep appreciation for how RWE integrates with drug development, regulatory affairs, medical, safety, and other functional areas.

Requirements

PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post-doctoral experience, preferably in the 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 supporting 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.
Demonstrated ability to function with an increasing level of autonomy.
Ability to develop productive cross-functional collaborations in a matrix environment.
Ability to manage priorities and performance targets.
Extensive experience conducting cancer epidemiology studies (solid tumor experience a plus).
Extensive experience with commercial Oncology EMR databases.
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.

Nice To Haves

A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
Experience in leading drug development projects for 2+ years for the therapeutic area of assignment is preferred.
Experience with Clinico-genomic multi-modal data (e.g., Tempus AI) or population biobank data (UK biobank) is a plus.

Responsibilities

Lead the development of study protocols, analysis plans, and study reports to address priority research questions for 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 responding to regulatory authorities or performing rapid analyses of safety queries.
Lead the identification of suitable data sources for the timely execution of the RWE strategy.
Construct cohorts using Real-World Data (RWD) 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 developing relevant sections of regulatory documents, reports, publications, and white papers.
Support the effective communication of study/analysis results to inform internal and external decisions.
Coauthor abstracts and manuscripts for external dissemination of methodologic study results.
Contribute to the development of processes and training to enhance the efficiency, quality, and impact of functional activities.
Leverage RWE expertise to identify evidence gaps and develop strategies to address them in support of early-phase (ph1/2) Clinical Development Programs.
Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (e.g., claims, EHR, registry data) for methodologic research questions.