Associate Principal Scientist
2 weeks ago
Job Title: Associate Principal Scientist
Location: West Point, PA 19486 OR Rahway, NJ, 07065 (Possibly)
Duration: 24 Months; Hybrid (3 days onsite between Monday-THRU)
Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist is responsible 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. Working closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations, the Associate Principal Scientist ensures COA endpoint strategies are consistent with and correctly executed to support the product strategy.
Primary Activities:- Coordinate global COA/PRO strategic plans in alignment with product franchise goals.
- Assist with the selection and/or development of COA/PRO instruments for inclusion in studies.
- Guide the implementation of COA/PRO instruments into studies following standard processes.
- Facilitate alignment of appropriate endpoint measures to satisfy regulatory and reimbursement needs.
- Coordinate COA/PRO-related sections of evidence packages for submission to regulatory and reimbursement agencies.
- Coordinate the development, validation, implementation, and utilization of instruments for measuring COA/PROs in clinical trials and/or observational studies.
- Conduct literature searches to support COA/PRO endpoint strategies.
- Support/produce scientific communications such as abstracts, poster presentations, podium presentations, manuscripts, etc.
- Keep up-to-date with COA/PRO methodologies and guidelines, communicating 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.
- Familiarity with COA/PRO requirements for regulatory and reimbursement agencies.
- Knowledgeable of methodological approaches and technical aspects 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.
MS Office suite
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