PhD in Epidemiology plus a minimum of 4 years of experience within a pharmaceutical company or pharma consulting environment. Master's in Epidemiology plus 7-9 years of experience in lieu of a PhD may be considered.
Experience designing and conducting RWE studies using claims (IQVIA Pharmetrics plus preferred) and registry data to support clinical trial design required. Familiarity with regulatory context required.
Ability to interpret and troubleshoot analytic outputs; hands-on programming not required.
Significant publication experience required.
Leadership experience required, including collaboration with programmers, epidemiologists, and KOLs.
What's 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 IQVIA's global network who supports your growth.
This is your chance to make an impact, while building a career that matters.
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 a
Benefits
Health insuranceRemote work options
Additional Information
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.
Core Function Description:
This role will support the Real World Evidence team focused on Inflammation with an emphasis on Inflammatory Bowel Disease (IBD), playing a key part in designing and executing real-world evidence studies that inform clinical development strategy, including clinical trial design and external evidence generation.
This position requires a senior-level epidemiologist to provide scientific oversight across complex observational research, with a focus on treatment pathways, patient journey, and outcomes such as monotherapy versus combination therapy. The role involves working extensively with secondary data sources, including claims and registry data, and partnering with internal teams, vendors, and external academic collaborators.
This is a fully remote position based in the United States.
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.
IQVIA · Durham, NC