Clinical Outcome Assessment Analyst

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing

• Execute and ensure the effective execution of work plans resulting in the development of relevant, reliable, and timely evidence for patients, regulators, clinicians, caregivers, and payers including:

• Design and execution of research to inform COA strategy development

• Develop and execute psychometric analysis strategy

• Support clinical trial development for assigned programs, including relevant portions of protocols, statistical analysis plans, study reports, briefing books, and related documents

• Identify gaps in available evidence needed to support fit-for-purpose use of COAs in a specified context

• As needed, design and execute research to develop or modify COA instruments for inclusion in assigned programs

• Consult on COA regulatory strategy

• Create and oversee the creation of scientific materials that are submitted to regulators ensuring consistent quality

• Develop publications of early COA research for disclosure in peer-reviewed journals and at scientific meetings

• Ensure effective packaging of information and scientific materials for patients and caregivers for dissemination and disclosure

• Develop effective working partnership with project management teams which enable teams to deliver planned work

• Ensure regular and transparent communication of project status to team members

• Ensure that appropriate measures and metrics are in place.

Your profile:

• 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.

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply