Clinical Outcomes Assessment (COA) Analyst – Part-Time (Remote, United States)
Company: ICON plc
Job Type: Part-Time (0.5 FTE)
Work Model: Remote
Locations: United States (Blue Bell, PA; Indianapolis, IN; Cary, NC; Houston, TX; Miami, FL; and additional US locations)
Experience Required: Minimum 3+ Years in COA Development and Psychometric Analysis
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies across all phases of drug development. The organization partners with sponsors to generate high-quality evidence that supports regulatory approvals, reimbursement decisions, and patient-centered innovation.
Job Overview
ICON plc is hiring a Clinical Outcomes Assessment (COA) Analyst to support the design, validation, and regulatory application of COA strategies within clinical development programs.
This part-time remote position is suited for professionals with expertise in psychometrics, patient-reported outcomes (PROs), regulatory guidance (FDA/EMA), and patient-focused drug development frameworks. The role contributes to the generation of scientifically rigorous evidence for regulators, clinicians, payers, patients, and caregivers.
Key Responsibilities
COA Strategy and Research Execution
Design and execute research supporting COA strategy development.
Identify evidence gaps required for fit-for-purpose use of COAs in specific clinical contexts.
Develop or modify COA instruments for integration into assigned programs.
Consult on global COA regulatory strategy.
Psychometric and Statistical Analysis
Develop and implement psychometric analysis strategies.
Conduct statistical analyses using tools such as SAS, R, Mplus, or equivalent platforms.
Ensure reliability, validity, and regulatory compliance of COA instruments.
Clinical Trial Support and Documentation
Contribute to clinical trial protocols, statistical analysis plans (SAPs), study reports, and regulatory briefing books.
Prepare scientific materials for submission to regulatory authorities.
Support audit and inspection readiness related to COA documentation.
Regulatory and Scientific Communication
Ensure alignment with FDA Patient-Focused Drug Development (PFDD) guidance and EMA standards.
Develop peer-reviewed publications and conference materials related to COA research.
Translate complex scientific findings into accessible materials for patients and caregivers.
Cross-Functional Collaboration
Partner with project management teams to ensure timely execution of deliverables.
Maintain transparent communication regarding project status and milestones.
Implement appropriate metrics to monitor study and program performance.
Required Qualifications and Experience
Master’s degree or PhD in Psychology, Psychometrics, Biostatistics, Health Outcomes Research, or related field.
Minimum 3+ years of experience in COA development, validation, and/or application in pharmaceutical, biotechnology, or CRO environments.
Strong knowledge of FDA and EMA regulatory guidance related to Clinical Outcomes Assessments and Patient-Focused Drug Development.
Demonstrated experience with psychometric methodologies and statistical analysis software (e.g., SAS, R, Mplus).
Experience contributing to regulatory submissions and clinical development documentation.
Strong understanding of evidentiary standards for PROs, ObsROs, ClinROs, and PerfOs.
Excellent written and verbal communication skills with the ability to synthesize complex data.
Proven ability to manage multiple projects independently in a remote environment.
Preferred Expertise
Experience across multiple therapeutic areas.
Knowledge of global regulatory frameworks impacting COA label claims.
Background in pharmaceutical commercialization and payer evidence strategy.
Compensation and Benefits
ICON offers competitive compensation and country-specific benefits designed to support employee well-being and work-life balance. Benefits may include:
Health insurance options
Retirement savings programs
Paid leave entitlements
Life assurance
Employee Assistance Programs
Flexible voluntary benefit options
ICON is committed to maintaining an inclusive, accessible, and discrimination-free workplace. All qualified applicants will receive equal consideration for employment.
Who Should Apply?
This opportunity is ideal for:
Health Outcomes Researchers
Psychometricians
Patient-Reported Outcomes (PRO) Specialists
Regulatory Strategy Professionals (COA Focus)
Clinical Research Scientists with COA expertise
If you have experience in Clinical Outcomes Assessment strategy, psychometric validation, and regulatory compliance within drug development, this part-time remote role offers strong exposure to global clinical development programs.
For more global clinical research, regulatory affairs, health outcomes, and life sciences job opportunities, visit ThePharmaDaily.com.
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