Epidemiologist, Virology, Real World Evidence (FSP Sponsor Dedicated)

IQVIA•Durham, NC

3d•Remote

About The Position

Join IQVIA’s Sponsor-Dedicated FSP team and help advance healthcare through real-world evidence. We bring together scientific expertise and real-world data to help sponsors make decisions and accelerate evidence generation to improve patient outcomes. In this role, you’ll work closely with one sponsor, gaining deep knowledge of their therapies while leveraging IQVIA’s global expertise.

Requirements

Observational research methods (both Primary and Secondary Data Collection), deep knowledge of biostatistics and analysis methods, and understanding of regulatory processes.
Protocol writing, SAP, manuscript and abstract writing.
PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of two (2) 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 five (5) years of experience in lieu of PhD may be acceptable.
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.
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.

Nice To Haves

A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.

Responsibilities

Design and conduct epidemiological studies to generate real-world evidence within 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 outcomes, comparative safety and effectiveness research, and post-authorization studies.
Developed and executed under Scientific Oversight study protocols, analysis plans, and study reports to answer research questions of priority to RWE.
Designed and managed epidemiological, biomarker and/or data science projects.
Planned, designed, and conducted analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries).
Supported the identification of fit-for-purpose data for the timely execution of the RWE 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.
Conducted analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questions.
Contributed to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers.
Supported the effective communication of study/analysis results to support internal and external decisions.
Coauthored abstracts and manuscripts for external dissemination of methodologic study results.
Contributed to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities.