Part-Time Epidemiologist
Indam Inc - New York, NY

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Major Responsibilities:

The exact schedule will be discussed later on depending on the selected candidate's availability

Description: Epidemiologist/Research Assistant Major

Responsibilities:
• Conduct literature reviews and other background research needed for various regulatory documents and regulatory requests including
- Epidemiology sections of the Risk Management Plans ( RMP ), Pediatric Investigational Plans ( PIP ), Periodic Benefit Risk Evaluation Reports ( PBRER ) and orphan drug applications
- Epidemiology sections for other regulatory documents (e.g. ad-hoc regulatory requests)
• Provide critical assessment of epidemiological data and literature relevant to safety issues
• As needed, conduct quantitative analyses of public use and private data sources as needed
• As needed, assist Epidemiologist with other components of Epidemiology deliverables for development and product teams, including: – Epidemiology Research Strategy – 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) • Support multiple product teams on epidemiology related issues as needed
• Work collaboratively with key stakeholders internally and externally
• Supervised by Director, Epidemiology, formally reports to the Epidemiology Business Unit Team Lead Client Management

Responsibilities:

• Safety and Risk Management Leads, Clinical, Medical, Regulatory Professional Background and Experience
• Doctorate or MPH in Epidemiology or related public health discipline or equivalent;
• 2 years or more in epidemiology in the pharmaceutical industry, academia, and/or regulatory agencies
• In-depth understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis
• Excellent written and verbal communication skills
• Ability to manage multiple projects simultaneously
• 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

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