Do you want an exciting position working with multiple teams to generate real world evidence supporting a wide variety of business needs?
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world, and is developing a pipeline of medicines with breakaway potential.
Observational Research is an increasingly important component in drug development and commercialization. There is increased demand for information from Real-World Data (RWD) studies for regulatory and reimbursement authorities. The Center for Observational Research (CfOR) at Amgen partners with teams to generate real world evidence for multiple stakeholders across the product lifecycle. CfOR studies include but are not limited to evidence generation regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, treatment cost and utilization patterns, and the safety and effectiveness of therapeutic interventions.
Amgen is seeking an Epidemiology Analyst (RWD researcher) to join our CfOR organization based in Hyderabad, India. In this role, the individual will contribute to research activities in the Data and Analytics Center (DAC) on functionally aligned teams. The ideal candidate should have strong knowledge of observational research methodology, excellent communication skills, attention to detail, and the ability to work across various therapeutic areas and regions. The Epidemiology Analyst is recognized as a strong scientific contributor and is a first or contributing author for papers in peer-reviewed journals, abstracts for scientific congresses or for internal reports that enhance the company’s mission.
Key Activities include:
Contribute to global observational research activities for CfOR in support of drug development, registration, and commercialization across Amgen’s portfolio of products
Contribute to the implementation and conduct of observational studies to support the product lifecycle using real world databases and analytics platforms (e.g., Atlas, Aetion, and other internal/external RWD tools)
Develop, review, and maintain high-quality medical codelists for exposures, outcomes, covariates, and safety endpoints using standard coding systems (e.g., ICD, MedDRA, SNOMED, RxNorm), ensuring clinical validity and regulatory readiness
Partner with study team members to ensure codelists are fit-for-purpose, transparent, and reproducible across studies
Executes/manages descriptive epidemiologic studies to characterize the incidence/prevalence of disease in US, EU, Asia, and emerging market countries
Executes/manages research projects involving the analysis of multiple types of data including medical claims, electronic health records, and prospective observational cohort studies
Provides safety research support across the life cycle of Amgen products, supports the development of risk management plans, and executes pharmacovigilance studies
Conducts literature reviews and prepares research reports and scientific manuscripts
Stays abreast of the latest developments in the field of observational research and drug development
Promotes awareness, understanding, and use of observational research methods
Communicates significant scientific information to a variety of audiences
Preferred Qualifications:
MBBS (or equivalent) and/or PhD training in Epidemiology or other subject with high observational research content
Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting
Advanced expertise in medical codelist construction, maintenance, and quality assurance across standard clinical coding systems (e.g., ICD, MedDRA, SNOMED)
Experience in research to support drug development
Experience working with secondary data systems, including administrative claims, EMR, registries
Experience in observational research project planning and management
Excellent verbal and writing communication and interpersonal skills
Experience working in multi-disciplinary teams
Basic Qualifications:
Master's degree with 8 to 13 years of experience
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