Observational Research Senior Manager

Observational Research Senior Manager

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 (OR) is an increasingly important component in drug development and commercialization. There is increased demand for information from OR 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 Observational Research Senior Manager (Epidemiologist/RWD researcher) to join our CfOR organization based in Hyderabad, India. This senior manager will report into a global epidemiology lead and will have responsibilities for designing, executing, and ultimately overseeing, key research activities across the CfOR Data and Analytics Center and across therapeutic areas. 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.

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 development of proposals, protocols, statistical analysis plans, and other observational study documents to support the product lifecycle
• Contribute to the implementation and conduct of observational studies to support the product lifecycle using real world databases
• Review and interpret study results and create manuscripts, reports and other deliverables summarizing the study results for a variety of audiences
• Contribute to the development and industrialization of foundational epidemiologic capabilities, including but not limited to the areas of medical code list development, literature reviews, pharmacovigilance, and forecasting
• Develop, lead, and mentor a team of epidemiologists and data scientists based in Hyderabad to support the above activities
• Track business and functional priorities and align resources against those priorities
• Contribute to the mission of CfOR, including progressing innovative epidemiological methods and analytical capabilities to support CfOR's leadership role within Amgen and industry
• Contribute towards building academic, data, and other relevant partnerships within the biopharmaceutical sector in India in the area of real world evidence, epidemiology, and real world data

Preferred Qualifications:

• Doctorate 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
• 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:

Doctorate degree and 2 years of scientific experience

OR

Master's degree and 6 years of scientific experience

OR

Bachelor's Degree and 8 years of scientific experience

OR

Associate's degree and 10 years of scientific experience

OR

High school diploma / GED & 12 years of scientific experience