Observational Research Senior Manager

at  Amgen

JOIN AMGEN’S MISSION OF SERVING PATIENTS

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

BASIC QUALIFICATIONS:

Doctorate degree and 2 years of related research and scientific experience
Or
Master’s degree and 4 years of related research and scientific experience
Or
Bachelor’s degree and 6 years of related research and scientific experience
Or
Bachelor’s degree and 10 years of related research and scientific experience
Or
High School diploma / GED and 12 years of related research and scientific experience

PREFERRED QUALIFICATIONS:

• Doctorate in Epidemiology or other subject with high observational research content.
• Experience in the design, execution and analysis of observation research studies within Pharmaceutical and/or Public Health settings.
• Experience in research to support drug development.
• Experience working with secondary data systems including administrative claims, EMR and registries.
• Experience in observational research project planning and management.
• Excellent communication, presentation and interpersonal skills.
• Experience working with and leading multi-disciplinary teams.

WHAT YOU WILL DO

Let’s do this. Let’s change the world. Are you searching for a new, dynamic opportunity working with multiple teams to generate real world evidence supporting a wide variety of business needs? If so, we invite you to explore Amgen’s Center for Observational Research.
With a constantly growing demand for information from regulatory and reimbursement agencies, Observational Research (OR) is a critical component in drug development and commercialization. Amgen’s Center for Observational Research (CfOR) partners with internal and external teams to generate real world evidence for multiple partners across the entire product lifecycle. We generate evidence to inform the frequency, distribution, clinical burden, natural history, and clinical course of disease, the design of clinical trials, health resource utilization, drug utilization patterns, and the safety and effectiveness of our medicines.
Amgen is searching for an Observational Research Senior Manager (Epidemiology), who will be part of the Data Strategy team, and will lead activities for enabling the use of high-quality real-world data to meet priority evidence generation needs across Amgen’s portfolio. This vital role will have responsibilities for gathering insights and building collaborations and capabilities to advance the generation, use, and dissemination of real-world evidence (RWE) related to disease state epidemiology, treatment patterns, and medication safety and effectiveness to inform regulatory decision making and enhance access and use of Amgen’s medicines.

RESPONSIBILITIES

• Conduct data landscaping reviews and data gap analyses to identify strategic opportunities to meet real-world evidence needs with fit-for-purpose real-world data
• Conduct evaluations of real-world data to ensure data meet standards for quality, validity, completeness, reliability and applicability
• Lead the design, generation and delivery of RWE to validate the use of real-world data sources for identifying the patient populations and outcomes needed to assess the safety and effectiveness of our medicines – to inform regulatory decision making and fulfill regulatory requirements across the globe.
• Negotiate with cross-functional partners and enhance the use of RWE that can substitute for and/or complement interventional studies to reduce the time and cost of drug development and answer key business questions.
• Facilitate the dissemination of RWE through publications, congress presentations, trainings, and development of scientific/promotional resources targeting a broad base of external partners (e.g., health care providers, payers, integrated delivery networks).
• Contribute to the development and implementation of innovative analytic methods, and leverage CfOR’s internal data and analytics capabilities and tools to enable rapid, scalable and reproducible RWE.
• Build external partnerships that can provide access to databases that can improve the quality and availability of real-world data in different patient populations and countries and facilitate execution of methodologically rigorous studies.
• Contribute to CfOR’s mission in progressing innovative epidemiological methods and analytical capabilities to support CfOR’s leadership role within Amgen and across industry.