Under the general direction of the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead, the Senior Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas. The individual will support the PaCES lead on the development, validation, analysis and interpretation of COA endpoints to support overall product development.
The Senior Scientist will work closely with the PaCES lead to collaborate with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and executed and interpreted to support the product strategy.
Primary activities include but are not limited to:
• Provide assistance on the selection and/or development of COA/PRO instruments for inclusion in studies
• Supporting the PaCES lead to providing guidance on implementing COA/PRO instruments into studies by following standard processes
• Attending Clinical Trial Team (CTT) meetings on behalf of the PaCES lead to facilitate alignment of the selection of an appropriate endpoint measure for inclusion in clinical trials
• Assist with coordination of COA/PRO related sections of evidence packages to be submitted to regulatory agencies
• Support the PaCES lead to coordinating 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 and/or 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 the PaCES team
Education:
• Master’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 3+ years of relevant work experience in the pharma industry OR Bachelor’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 5+ years of relevant work experience in the pharma industry
Required Experience:
• Familiar with COA/PRO requirements for regulatory and reimbursement agencies
• Knowledge 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 scientific presentations and publications.