• Contract
  • Remote

SimulStat

6-month renewable remote contract

Key Responsibilities:

  • Support targeted research of epidemiology of specific disease areas, including incidence/prevalence, BOI, and NH of disease for business development and early development indications
  • Contribute to registry strategy for early development and early clinical indications to support BOI or NH of disease needed for regulators, payers, and clinicians
  • Lead and execute evaluation of available registries and other data sources related to BOI or NH
  • Determine potential use of RWE historical control within clinical development program and feasibility of obtaining data required for historical control
  • Assist in the development of novel AOP tactics proposed for programs currently in clinical development based on cross-functional program needs
  • Support execution of approved AOP tactics within assigned indications
  • Support Study Execution Teams for observational studies
  • Develop draft protocol concept and related materials for review and approval by NIPPRC and Statistical Review Forum
  • Contribute to development of performance metrics and dashboards for RWE projects
  • Represent RWE on relevant GMDA Sub-Teams, Program Teams, or Disease Strategy Teams where studies related to RWE, BOI, or NH are discussed
  • Represent RWE on cross-functional collaborations and working groups for pipeline product(s)
  • Utilize strong communications skills and understanding of strategies to promote and translate RWD/RWE methods and activities across the company
  • Contribute to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of RWE studies

Minimum Qualifications:

  • PhD in Epidemiology
  • Formal training in Epidemiology/Health Services Research required
  • Minimum 3 years of experience working in observational research within the life sciences industry or relevant academic, government, or consulting environment
  • Extensive experience with registry data and/or claims data and/or electronic medical records.

Preferred Qualifications:

  • Good amount of pharma experience (inside a company)
  • Understanding of the 21st Century Cures Act and the opportunities for use of RWE to inform regulatory decision makers
  • Demonstrated ability to design and execute observational research
  • Strong interpersonal communication and study management skills
  • Ability to take detailed observational study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings
  • Ability to work effectively in a constantly changing, diverse, and matrix environment
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