Medical - Clinical Research Associate III(12831-1)

Incedoinc - Collegeville, PA

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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)

  • 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
  • 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
  • PhD in Epidemiology, DrPH or SCD (preferred)
  • MS in Epidemiology or MPH with a concentration in epidemiology

Job Type: Contract

Salary: $40.00 to $45.00 /hour

Experience:

  • STATA: 1 year (Preferred)
  • Statistical Software: 1 year (Preferred)
  • SPSS: 1 year (Preferred)
  • SAS: 1 year (Preferred)

Education:

  • Master's (Preferred)