EpidemiologistSenior Epidemiologist, Inflammation, EHR Expertise (FSP Sponsor Dedicated)

Core Function Description:

This role will support real-world evidence generation using secondary data sources with a focus on studies leveraging EHR chart review data and disease registries primarily from academic settings. This role will play a key part in designing and executing observational research that supports effectiveness and efficacy questions with an emphasis on data quality study execution and operational considerations.

This position requires an epidemiologist with strong experience working across multi-database environments including coordinating and integrating data from EHR systems and registries. The role involves ensuring studies are designed and conducted in alignment with regulatory requirements for EHR data included in FDA submission packages with a strong understanding of real-world data.

Required Experience

• Lead development of study protocols analysis plans and study reports to answer research questions of priority to RWE.

• Lead design and manage epidemiological biomarker and/or data science projects.

• Lead plan design and conduct analyses for internal and external decision making (e.g. responses to regulatory authorities rapid analyses of safety queries).

• Lead 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.

• 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 decisions.

• 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:

• Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims EHR PRO/COA registry data) for methodologic research questions.

• Deep hands-on familiarity with EHR data curation behind health system firewalls including practical knowledge of where key clinical outcomes are captured across data tables.

• Expert knowledge and extensive experience with pharmacoepi methods (i.e. signal detection and validation methods).

• Leverage RWE expertise to identify evidence gaps and develop options to address the evidence gaps in support of Clinical Development Programs.

Minimum Qualifications

• PhD in Pharmacoepidemiology; or PharmD with Masters/PhD in Epidemiology; or MD with Masters/PhD in Epidemiology required.

• Experience in multi-database secondary data studies (chart reviews/EHR/registries) used for effectiveness and efficacy required.

• Strong understanding of regulatory requirements related to EHR data use in FDA submission packages.

• Familiarity with standard healthcare data structures including billing codes diagnostic codes and EHR-derived variables.

• Strong collaboration skills ability to work across cross-functional teams and external partners.

Whats in it for you

• Be part of a forward-thinking team that helps shape the next generation of evidence-based healthcare.

• Work hand-in-hand with one leading sponsor gaining deep expertise in their therapies.

• Access IQVIAs global network who supports your growth.

This is your chance to make an impact while building a career that matters.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.