ICON Strategic Solutions · 1 day ago
Clinical Outcomes Assessment Analyst
United States
Full-time
Remote
Mid Level
3+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. The Clinical Outcomes Assessment Analyst will execute work plans to develop reliable evidence for stakeholders and support clinical trial development, ensuring effective communication and project management.
Pharmaceuticals
Responsibilities
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
Qualification
Required
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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
Company data provided by crunchbase