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.