Amgen Observational Research Sr Mgr in Thousand Oaks, California
The Observational Research (OR) is an important component of drug development and commercialization. Some areas where OR contributes include estimating the size of treatable populations, characterizing the clinical burden of disease, and through use of pharmacoepidemiology to evaluate drug safety, effectiveness and
support design of clinical trials. Increasingly, data obtained from observational studies are required by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) has been created to address this imperative. The OR Sr. Manager will be a major contributor within the Data and Analytic Center within CfOR, and will report directly to the Descriptive Epi functional lead. This position will be located at Amgen's Thousand Oaks headquarters or remotely in the US. An OR Sr. Manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer reviewed journals or for internal reports that enhance the company's mission.
Key Activities Include
Contributes to research strategy within the product team and observational research TA
Responsible for designing and conducting high-quality observational research studies to support product strategy.
Contributes to pharmacovigilance activities including safety signal detection, surveillance, and risk management plans.
Is actively involved in scientific collaborations with key leaders in observational research.
Promotes understanding and use of state of the art observational research methods.
Communicates scientific strategy and results to a variety of internal/external audiences
Doctorate degree and 2 years of clinical experience
Master's degree and 6 years of clinical experience
Bachelor's degree and 8 years of clinical experience
Associate's degree and 10 years of clinical experience
High school diploma / GED and 12 years of clinical experience
PhD/DSc in Epidemiology or other subject with high observational research content and 3+ years experience or MD with 3+ years observational research experience.
Experience in the design, execution, and analysis of observation research studies within Pharmaceutical or Public Health setting
Record of publications in peer reviewed journals
Experience in research to support drug development
Proficient communicating observational research information (written and oral)
Experience working in multi-disciplinary teams
Knowledgeable in observational research databases, study designs and analysis
Use of observational research in Drug Development
Programming in SAS or other software (e.g. STATA)
Literature search methods
Knowledge of adverse drug experience data
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.