Outcomes Research Manager

job summary:
This is a high-impact opportunity to shape the future of oncology drug development by ensuring the patient's voice is at the center of clinical research. You will lead the strategy and execution of Patient Experience Data (PED), transforming complex clinical outcomes into compelling evidence that drives product registration and global market access. Working within a specialized research team, you will bridge the gap between rigorous statistical analysis and strategic clinical development.

You will be joining a world-class research facility renowned for its cutting-edge oncology pipeline and commitment to patient-centric innovation. This remote-based role offers the chance to work at the forefront of measurement science, utilizing advanced psychometric and statistical methods to validate Clinical Outcome Assessments (COA) that directly impact lives.

location: Telecommute
job type: Contract
salary: $50.00 - 55.32 per hour
work hours: 9 to 5
education: Masters

responsibilities:

• Lead COA Strategy: Design and integrate Clinical Outcome Assessment measurement strategies into clinical development programs, ensuring they are fit-for-purpose and regulatory-ready.
• Execute Quantitative Research: Conduct rigorous psychometric and statistical analyses, including factor analysis and reliability testing, to validate PRO/COA tools within oncology portfolios.
• Drive Clinical Integration: Collaborate with Clinical Development and Operations to author protocols and Statistical Analysis Plans (SAPs) that incorporate patient-centered endpoints.
• Regulatory Authoring: Develop high-level technical content for regulatory and reimbursement submissions, translating complex data into clear, persuasive narratives.
• Evidence Generation: Conduct literature and landscape reviews to build disease conceptual models that define the patient experience in specific oncology indications.
• Scientific Communication: Lead the publication process and present data-driven insights at major medical congresses and in peer-reviewed journals.
• Stakeholder Education: Act as a subject matter expert to internal teams, promoting best practices for quantitative PED/COA analysis across the organization.

qualifications:

Required Skills:

• Advanced degree (MS, MPH, PharmD, or PhD) in Biostatistics, Epidemiology, HEOR, Public Health, or a related quantitative field.
• Minimum of 3 years of direct research experience with hands-on quantitative and statistical analysis of PRO/COA data within clinical trials.
• Expertise in measurement science principles and advanced psychometric/statistical methods.
• Proven experience developing and implementing Statistical Analysis Plans (SAPs) for clinical outcomes.
• Strong project management skills with the ability to manage multiple competing priorities in a fast-paced environment.

Preferred Skills:

• Direct experience in Oncology research or oncology-specific PRO/COA validation.
• Familiarity with regulatory documentation requirements specifically for COA endpoints.
• Advanced statistical programming skills related to clinical trial endpoint analysis.

#LI-ST1

skills: Project Management, Oncology, Data Analysis, Statistical Analysis Plan, Statistical Programming, Economic Modeling, Health Economics, Real World Evidence (RWE), Cost Effectiveness, Budget Impact Modeling, Health Technology Assessment (HTA), Outcomes Research, Pharmacoeconomics, Systematic Literature Reviews (SLR), Meta Analysis and Indirect Treatment Comparison, Cost Benefit Analysis, Cost Utility Analysis, Patient Reported Outcomes (PRO), Observational Study Design and Execution, Claims Database Analysis, Electronic Health Record (EHR), HEOR Endpoints, Evidence Synthesis, Value Proposition Development, Market Access Strategy Support, Payer Engagement and Communication, Burden of Illness Studies, Quality of Life (QoL), Global Payer Landscape Understanding, Evidence Generation Planning


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.