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Search for Jobs by Melissa Grover

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REMOTE- Epidemiologist  (Science & Biotech)
san diego, CA 91222
Recruited by: Melissa Grover | Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: SimulStat Inc.
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Aug 27, 2020
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Job Description



-12 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 biostatistics, epidemiology, health economics and outcomes research, health policy, or similar required
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:

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