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Research Associate II
Ref No.: 18-27863
Location: Collegeville, Pennsylvania
Job Title: Epidemiology Research Associate II
Location: 500 Arcola Rd, Collegeville, PA 19426, USA
Duration: 12 Months
 
We are looking for an Epidemiologist (preferably with a PhD, DrPH or ScD)
 
Propose and carry out various components of Epidemiology deliverables for development and product teams, including:
  • Epidemiology Research Strategy
  • Epidemiology section of the Risk Management Plan (RMP) and Pediatric Investigational Plan (PIP)
  • Epidemiology sections for other regulatory documents (e.g., ad-hoc regulatory requests)
  • Background epidemiology studies, natural history of disease studies and user characterization studies
  • Post-approval safety studies and their feasibility assessments
  • Other epidemiology studies (e.g., special subpopulations, new indications)
 
Description:
  • Participate in Risk Management Committee activities and apply epidemiologic methods to address safety and benefit/risk issues
  • Provide critical assessment of epidemiological data and literature relevant to safety issues
  • Conduct quantitative analyses of public use and private data sources as needed
  • Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals
  • Support multiple product teams on epidemiology related issues
  • Work collaboratively with key stakeholders internally and externally
  • Interact with regulatory agencies on epidemiologic issues as needed
 
Skills:
    In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis
• Demonstrated ability to design and conduct high-quality epidemiological studies in the pharmaceutical industry, academia, and/or regulatory agencies
• Excellent written and verbal communication skills
• Ability to manage multiple projects simultaneously
• An understanding of drug development process, including regulatory aspects
Experience with statistical software packages (e.g., SAS, SPSS or Stata)
• In-depth knowledge of public and private epidemiologic resources and database
• Ability to collaborate effectively with experts from diverse disciplines
 
 
What is the minimum education experience required?:
 
PhD in Epidemiology, DrPH or SCD (preferred)
MS in Epidemiology or MPH with a concentration in epidemiology