Clinical Outcomes Assessment Analyst
Location
Florida + 2 moreAll locations: Florida, North Carolina, Texas
Posted
36 days ago
Salary
Not specified
Job Description
Job Requirements
- Master’s degree or PhD in psychology, psychometrics, biostatistics, health outcomes, or related field.
- Minimum 3 years of experience in COA development, validation, and/or application in clinical research (pharma, biotech, or CRO setting).
- Strong understanding of FDA and EMA guidance on COAs and patient-focused drug development.
- Proficiency in psychometric methods and statistical software (e.g., SAS, R, Mplus, or similar).
- Excellent written and verbal communication skills with ability to summarize complex data.
- Strong organizational skills and ability to manage multiple projects independently.
- Relevant drug development and/or commercialization experience within the pharmaceutical industry with strong knowledge of patient, regulator, and payer requirements.
- Significant demonstrated experience in developing and implementing strategies to apply scientific methods associated with the measurement, assessment and translation of the patient experience in multiple disease areas.
- Knowledge of the regulatory environment with particular knowledge of FDA Patient Focused Drug Development guidance, relevant guidance from other regulatory bodies, and evidentiary standards for Clinical Outcomes Assessment (e.g. PROs, ObsROs, ClinROs, PerfOs) label claims.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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