Clinical Outcomes Assessment Analyst

IRE • Indianapolis, IN

20d

About The Position

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.

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.

Responsibilities

• 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.

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.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level