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Epidemiologist Contractor
Ref No.: 18-12848
Location: Collegeville, New York
Start Date / End Date: 11/19/2018 to 11/18/2019
Contractor Work Location: Collegeville - PA
Job Title: Epidemiologist Contractor
Duration: 12 Months

: We are looking for an Epidemiologist (preferably with a PhD, DrPH or ScD)

Job Description
JOB TITLE: Epidemiologist Contractor
• 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
Additional 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