Sr. Associate, observational research

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

o   Executes/manages research projects involving the analysis of multiple types of data including medical claims, electronic health records, and prospective observational cohort studies

o   Provides safety research support across the life cycle of Amgen products, supports the development of risk management plans, and executes pharmacovigilance studies

o   Conducts literature reviews and prepares research reports and scientific manuscripts

o   Stays abreast of the latest developments in the field of observational research and drug development

o   Promotes awareness, understanding, and use of observational research methods

o   Communicates significant scientific information to a variety of audiences

Preferred Qualifications:

o   MBBS (or equivalent) and/or PhD training in Epidemiology or other subject with high observational research content

o   Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting

o   Advanced expertise in medical codelist construction, maintenance, and quality assurance across standard clinical coding systems (e.g., ICD, MedDRA, SNOMED)

o   Experience in research to support drug development

o   Experience working with secondary data systems, including administrative claims, EMR, registries

o   Experience in observational research project planning and management

o   Excellent verbal and writing communication and interpersonal skills

o   Experience working in multi-disciplinary teams

 

Basic Qualifications:

Doctorate/ PhD degree in a relevant discipline, or an MBBS (or equivalent clinical medical degree)OR

Master's degree and 3 years of scientific experience

OR

Bachelor's Degree and 5 years of scientific experience

.

Experience Level

Mid Level