Sr. Associate, observational research

Career Category Research Job Description Job Description: 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: o   Contribute to global observational research activities for CfOR in support of drug development, registration, and commercialization across Amgen’s portfolio of products o   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) o   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 o   Partner with study team members to ensure codelists are fit-for-purpose, transparent, and reproducible across studies o   Executes/manages descriptive epidemiologic studies to characterize the incidence/prevalence of disease in US, EU, Asia, and emerging market countries