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For your reference, we have included the original job posting below.
Observational Research Senior Manager Epidemiology Health Outcomes
Job Number:
41708834
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Clerical & Administrative Research
Observational Research Senior Manager Epidemiology Health Outcomes
Observational research (OR) makes important contributions to drug development and commercialization along with randomized clinical trials. OR contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, cost and utilization patterns, and the safety and effectiveness of interventions. In the current environment, there is increasing demand for information from OR studies by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) has been created to address this imperative.
Job Summary
The OR Sr. Manager is a major contributor within one of the CfOR Therapeutic Areas (Oncology, Bone, Cardio/Renal, General Medicine & Inflammation) and reports directly to a Product Lead.
This position will be located at Amgen's Thousand Oaks headquarters.
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 conducting high-quality observational research to support product strategy within TA • Executes safety signal detection and management • Provides safety surveillance across the life cycle of Amgen products • Support preparation of PSRM materials • Executes process of patient exposure estimation for marketed products • Supports development of risk management plans • Supports relationships with key leaders in observational research • Sets annual product-specific and personal goals • Provides input into observational research department meetings • Stays abreast of the latest developments in the field of observational research and drug development and contributes to the field • Promotes observational research awareness • Promotes understanding and use of state of the art observational research methods • Communicates significant scientific information to a variety of audiences
Basic Qualifications Doctorate degree & 2 years of directly related experience OR Master's degree & 6 years of directly related experience OR Bachelor's degree & 8 years of directly related experience OR Associate's degree & 10 years of directly related experience OR High school diploma / GED & 12 years of directly related experience
Preferred Qualifications • Masters (PhD preferred) degree in Epidemiology or other subject with high observational research content or Medical degree with observational research experience • 6 years experience in observational research • Record of publications in observational research or clinical journals • 3 years experience with Medical or Doctorial degree • Experience in the design, execution, and analysis of observation research studies within Pharmaceutical or Public Health setting • Experience in research to support drug development • Experience in observational research project planning and management • Experience communicating observational research information (written and oral) • Experience working in multi-disciplinary teams • Managerial experience
Knowledgeable in • Basic observational research study designs and analysis • Programming in SAS or other software (e.g. STATA) • Literature search methods • Observational research methodology and applications within Drug Development • Drug development process and operations • Observational research databases • Knowledge of adverse drug experience data
