Senior Epidemiologist, Immunology, RWE (FSP Sponsor Dedicated)
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. Core Function Description: This role will support the Inflammation, Real World Evidence team, providing scientific and strategic epidemiology support for clinical development and drug safety activities. This role will leverage secondary real-world data (RWD) sources to generate evidence that informs regulatory, safety, and clinical development decisions across the product lifecycle. The Senior Epidemiologist will collaborate closely with cross-functional teams, including Clinical Development, Safety, Regulatory Affairs, Biostatistics, and Real-World Evidence stakeholders, to ensure appropriate epidemiologic approaches are applied to address critical business and scientific questions. The ideal candidate will have deep expertise in epidemiologic methods, demonstrated experience working within pharma or biotech, and a thorough understanding of regulatory requirements related to clinical development and safety evidence generation. This is a fully remote position based in the United States.
Requirements
- Doctoral degree (PhD, ScD, or equivalent) in Epidemiology.
- 5 to 7 years of epidemiology experience within a pharmaceutical/biotechnology company.
- Demonstrated experience supporting clinical development and/or drug safety.
- Strong expertise in observational research methods and the use of commercial healthcare databases such as HealthVerity, Pharmetrics Plus, TriNetX, or similar real-world data assets.
- Solid understanding of regulatory requirements and evidence needs supporting clinical development, including the generation of evidence to address regulatory questions related to safety profiles and evidence gaps for Phase II and Phase III programs.
- Proven ability to design, execute, and interpret epidemiologic studies that support regulatory, clinical, or safety objectives.
Nice To Haves
- Experience in Inflammation and Immunology therapeutic areas.
- Knowledge of disease areas such as Atopic Dermatitis, Asthma, Lupus, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia, or other immune-mediated diseases.
- Experience supporting assets within emerging immunology programs.
- Experience working with primary or hybrid real-world data sources in addition to secondary data sources.
- Prior experience supporting regulatory submissions or interactions with FDA, EMA, or other global health authorities.
Responsibilities
- Designing and conducting observational research studies
- Assessing evidence gaps
- Evaluating safety profiles
- Developing evidence strategies to support regulatory interactions and clinical development programs
- Collaborating closely with cross-functional teams, including Clinical Development, Safety, Regulatory Affairs, Biostatistics, and Real-World Evidence stakeholders, to ensure appropriate epidemiologic approaches are applied to address critical business and scientific questions.
Benefits
- Access IQVIA’s global network who supports your growth.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
