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Observational research (OR) is an increasingly important component in drug development and commercialization, because in the current environment, 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.
Job Responsibility:
Design and execute studies based on causal inference frameworks to support evidence generation such as identifying appropriate patient populations, assessing disease burden and resource utilization, obtaining product registrations and label-expansions, meeting post-marketing requirements/commitments, and product differentiation
Identify opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development
Influence cross-functional stakeholders as to the appropriate use and timing of non-interventional research to answer high-priority strategic business questions
Leverage real-world data and CfOR analytic approaches to inform high-value business decisions for multiple stakeholders
Contribute to the mission of CfOR, including progressing innovative epidemiological methods and analytical capabilities to support CfOR’s leadership role within Amgen and industry
Requirements:
Doctorate degree and at least 2 years of related research and scientific experience
Master's degree and at least 6 years of related research and scientific experience
Bachelor’s degree and 8 years of data sciences and scientific experience
Associate’s degree and 10 years of data sciences and scientific experience
High school diploma / GED and 12 years of data sciences and scientific experience
Nice to have:
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 applying causal inference frameworks such as target trial emulation or the causal roadmap to generate real-world evidence
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
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible