Senior Epidemiologist, Immunology, RWE (FSP Sponsor Dedicated)

NCBioImpact; Durham (NC); À distance; USD 109 000 - 273 000; Plein temps

Résumé du poste

IQVIA's Sponsor-Dedicated FSP team is seeking a Senior Epidemiologist to provide scientific and strategic epidemiology support for clinical development and drug safety activities. The role uses secondary real-world data to inform regulatory decisions across the product lifecycle.

The ideal candidate holds a doctoral degree in epidemiology with 5–7 years of pharma/biotech experience, and has deep expertise in observational methods and regulatory requirements related to safety evidence generation.

Qualifications

• Doctoral degree (PhD, ScD, or equivalent) in Epidemiology.
• 5–7 years of epidemiology experience in pharma/biotech.
• Experience supporting clinical development and/or drug safety.
• Strong expertise in observational research methods using real-world data assets.
• Knowledge of regulatory requirements for clinical development and safety evidence.
• Ability to design, execute, and interpret epidemiologic studies for regulatory/safety objectives.

Responsabilités

• Design and conduct observational research studies.
• Assess evidence gaps and evaluate safety profiles.
• Develop evidence strategies to support regulatory interactions and clinical development.
• Collaborate with Clinical Development, Safety, Regulatory Affairs, Biostatistics, and Real-World Evidence stakeholders.

Connaissances

Epidemiology expertise

Observational research

Regulatory knowledge

Pharma/biotech experience

Formation

Doctoral degree in Epidemiology

Outils

HealthVerity

Pharmetrics Plus

TriNetX

Description du poste

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.

Key responsibilities include designing and conducting observational research studies, assessing evidence gaps, evaluating safety profiles, and developing evidence strategies to support regulatory interactions and clinical development programs. 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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

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 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 https://jobs.iqvia.com

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. https://jobs.iqvia.com/eoe

IQVIA 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.

The potential base pay range for this role, when annualized, is $109,200.00 - $273,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.