Amgen

Observational Research Sr Mgr

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 16, 2019
Ref
R-75008
Required Education
High School or equivalent
Position Type
Full time
Observational Research (OR) is an important component of drug development and commercialization. Areas where OR contribute include estimating the size of treatable populations, characterizing the clinical burden of disease, supporting the design of clinical trials, and evaluation of drug safety and effectiveness. Increasingly, data obtained from observational studies are required by regulatory and reimbursement authorities. Amgen's Center for Observational Research designs, conducts, analyzes, interprets, and publishes observational research that informs the safety, efficacy, effectiveness, and economic value of Amgen products.

This role within the Data & Analytic Center in CfOR will use RWE to inform on the feasibility and design of our clinical development programs and significantly contribute to the advancement of our RWD platform. This position will report to the Descriptive Epi/Clinical Program Design lead and will be located at Amgen's Thousand Oaks headquarters.

Responsibilities include, but are not limited to:
  • Conduct research and collaborate with cross functional teams to generate high quality RWE to support Amgen's pipeline and in-line medicines
  • Build capabilities to advance our RWD platform, including the development of standardized epidemiology outputs to address key analytic needs and research questions.
  • Build strong collaborations with key stakeholders to support the adoption of the RWD platform.
  • Contribute to pharmacovigilance activities including safety signal detection, surveillance, and risk management plans


Basic Qualifications

Doctorate degree and 2 years of clinical experience

OR

Master's degree and 6 years of clinical experience

OR

Bachelor's degree and 8 years of clinical experience

OR

Associate's degree and 10 years of clinical experience

OR

High school diploma / GED and 12 years of clinical experience

Preferred Qualifications

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

Managerial experience

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