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Senior Research Scientist
2 months ago
Pacer Staffing is seeking a highly skilled Associate Principal Scientist to join our team. As a key member of our Patient-Centered Endpoints & Strategy (PaCES) group, you will be responsible for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas.
Key Responsibilities- 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.
- Provide assistance 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 Merck standard processes.
- 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.
- 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.
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.