AbbVie · 16 hours ago
Associate Director, Epidemiology - Immunology (Remote)
Chicago, IL
Full-time
Remote
Mid, Senior Level
3+ years exp
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Responsibilities
Lead or contribute to the development of real-world evidence, including study design, protocol and statistical analysis plan development, and execution using various data sources, such as administrative claims and health records data.
Conduct comprehensive literature reviews to support signal assessments, establish background rates for disease states, and develop risk management plans; synthesize and communicate results in both written and presentation formats.
Deliver epidemiology content for core safety and regulatory documents, such as RMPs, BRPAs, ODAs, Briefing Books, and MSAs; lead and participate in vendor or collaborator selection and the creation of study-related materials.
Advance epidemiology research and methodologies, providing expertise on novel and existing techniques to address benefit-risk questions; establish key scientific partnerships to enhance real-world methodologies and capabilities.
Collaborate with global epidemiology teams and key partners, including Pharmaceutical Development, Medical Affairs, HEOR, and Statistics, to achieve team goals.
Development of RWE studies to support asset and disease area strategies, in collaboration with cross-functional partners in Clinical Development, Medical Affairs, HEOR and others.
Qualification
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Required
PhD/PharmD with 3-5 years of experience, or MPH/MS with a minimum of 5 years of experience in epidemiology, outcomes research, or a related discipline.
Demonstrated high level of methodology and technical expertise in regulatory real-world methods, data sources, and study design.
Proven ability to clearly communicate epidemiology concepts, both verbally and in writing, to diverse audiences.
Knowledgeable in current and future policies, practices, trends, and developments affecting the business and organization; understands regulatory pharmaco-epidemiology.
Ability to negotiate skillfully in challenging situations with both internal and external groups, settle differences amicably, gain trust quickly, and effectively balance directness and diplomacy.
Comprehensive understanding of methods for adverse event collection and evaluation, signal detection, and signal validation.
Familiar with quality assurance, legal and regulatory functions, database functionalities, and management processes.
Knowledgeable of U.S. and international safety regulations and current regulatory safety review processes.
Preferred
Industry experience is preferred.
Company
AbbVie
AbbVie is a pharmaceutical company that discovers, develops, and markets medicines. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (155)
2022 (299)
2021 (194)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chief Executive Officer
A
Azita Saleki Gerhardt
Senior Vice President, Operations
Recent News
Silicon Republic
2024-12-18
2024-12-16
Company data provided by crunchbase
