Epidemiologist II

Clinical Outcome Assessment (COA) Instrument

A Clinical Outcome Assessment (COA) Instrument is a standardized formal perception-based clinical assessment instrument that quantifies a clinical study participant's health outcome. Types of COAs include Patient-reported outcome (PRO) measures, Observer-reported outcome (ObsRO) measures, Clinician-reported outcome (ClinRO) measures, and Performance outcome (PerfO) measures. PROs provide information on the patient's health condition as directly reported by the patient, without outside interpretation from anyone. How are patients feeling? Collect health status of patients and how to collect it? How do we make sure the correct questions are being asked to patients in the clinical trial? Patient reported data. Existing questionnaires to be included in the studies.

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.

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.

Responsibilities: Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal 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 teams on the development, validation, analysis, and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications. The Associate Principal Scientist will work closely with individuals from PaCES, 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.

Primary activities include but are not limited to: • 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 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.