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Epidemiologist
2 months ago
Title: Epidemiologist II
Location: West Point, Rahway (possibly)
Duration: 2 years
NOTE: Hybrid (3 days onsite between Monday-THRU)
Must have on resumes: COA endpoint strategies, PROs, patient inputs, regulatory interaction, literature review, prepare questionnaires for patients in the trial, review trial protocols and analysis plans.
Job Description:
- Responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas.
- The individual will support teams on the development, validation, analysis, and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.
- Work closely with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
- Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Clinical Trial Teams (CTT) and/or Clinical Sub-teams (CST) to assure alignment with product franchise goals.
- Aid on the selection and/or development of COA/PRO instruments for inclusion in studies.
- Provide guidance on implementing COA/PRO instruments into studies by following Client standard processes.
- Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs.
- Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies.
- Coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies.
- Conduct literature searches to support COA/PRO endpoint strategies.
- Support/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.)
- Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed.
Education:
PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 3+ years of relevant industry work experience in the COA field.
OR
Master's degree in health services research, Statistics, Psychometrics, Outcomes Research, or closely related field with 5+ years of relevant industry work experience in the COA field.
OR
bachelor's degree in health services research, Statistics, Psychometrics, Outcomes Research, or closely related field with 10+years of relevant industry work experience in the COA.
Required Experience:
- Familiar with COA/PRO requirements for regulatory and reimbursement agencies.
- Knowledgeable of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies.
- Ability to understand and respond to multiple internal and external customers.
- Strong project management and communication skills.
- Experience with COA/PRO-related scientific presentations and publications.