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Regulatory Real World Evidence
3 months ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Regulatory Real World Evidence (RWE), ManagerLive
What you will do
Lets do this Lets change the world. In this vital role you will be engaged in generating insights around the use of Real World Evidence (RWE) for regulatory decision making and will be a member of the Data and Analytics Center (DAC). A CfOR Manager is recognized as a scientific contributor and is a first or contributing author for papers in peer-reviewed journals, abstracts for scientific congresses or for internal reports that improve the companys mission.
Key Activities include:
Develop Statistical Analysis plans for observational studies and for studies combining RWD and clinical trial dataProvide support to therapeutic area teams for the design and execution of RWE studies related to regulatory filings.Supervises the evaluation and assessment of Real Word Data (RWD) for use as RWE in regulatory filings.Performs analysis of multiple types of data including medical claims, electronic health records, and prospective observational cohort studiesDesign, and develop using RWD external control groups as either external controls in single arm trials, or as augmentation to randomized control groups in RCTs using appropriate methodology (e.g., Bayesian dynamic borrowing approaches)Stays abreast of the latest developments in the field of observational research and drug development, and in particular, the US and global regulatory environment.Promotes awareness, understanding, and use of observational research methods across the organization.Communicates significant scientific information to a variety of audiences.Assists in the growth of the Regulatory RWE group in terms of methodology development, selection and evaluation of RWD sources.What we expect of you We are all different, yet we all use our unique contributions to serve patients. The senior manager we seek is an individual with these qualifications. Basic Qualifications:Doctorate degree and 2 years of related research and scientific experience OrMaster's degree and 6 years of related research and scientific experience OrBachelor's degree and 8 years of related research and scientific experience OrAssociate's degree and 10 years of related research and scientific experience OrHigh School diploma / GED and 12 years of related research and scientific experiencePreferred Qualifications:Doctorate in Epidemiology, Public Health, or Biostatistics with high observational research content.Experience in the design, execution, and analysis of observational research studies within Pharmaceutical, Academic or Public Health setting.Experience in research to support drug development.Experience working with secondary data systems, including administrative claims, EHRs, and registries.Experience in observational research project planning and management.Excellent verbal and written communication and interpersonal skillsExperience working in multi-disciplinary teams.Knowledge and experience in oncology research is an asset.Knowledge and experience with (any or all) of R, Python, SAS, or STATA programming and statistical analysis an assetKnowledge of methodological innovations related to the use of RWE with clinical trial data an asset (e.g., Bayesian dynamic borrowing)Familiarity working with imaging data (e.g., DICHOM files) such as PET/CT scans an asset. Knowledge of advanced methodologies used in observational research such as propensity score adjustment approaches to control for confounding, negative control outcomes to evaluate the presence of unmeasured confounding, inverse probability of censoring weighting to control for informative censoring, doubly robust adjustment approaches, and quantitative bias analysis.ThriveWhat you can expect of us As we work to develop treatments that look after others, we also work to care for our teammates professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply nowfor a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.