About the Role
The contractor will lead the development and execution of real world evidence and HEOR strategies to support regulatory and commercial objectives. This includes designing studies, analyzing real world data, and generating insights to demonstrate product value.
Responsibilities
- Design and manage real world evidence studies using claims, electronic health records, and registry data
- Collaborate with internal teams to align RWE initiatives with regulatory and market access goals
- Conduct health economics modeling and outcomes research to support value dossiers
- Analyze real world datasets to generate clinical and economic evidence
- Develop protocols and statistical analysis plans for observational studies
- Ensure methodological rigor and compliance with regulatory standards
- Present findings to internal stakeholders and external partners
- Support publication of results in peer-reviewed journals and conference abstracts
- Monitor evolving RWE methodologies and regulatory expectations
- Coordinate with external vendors and research partners
- Provide input on patient-reported outcomes and quality of life assessments
- Assist in the development of budget impact and cost-effectiveness models
- Translate clinical data into compelling value narratives
- Maintain up-to-date knowledge of disease area epidemiology and treatment patterns
- Support regulatory submissions with real world evidence components
- Evaluate data source quality and suitability for research objectives
- Contribute to HEOR strategic planning and evidence gap analyses
- Work with legal and compliance to ensure data privacy and regulatory adherence
- Manage timelines and deliverables for multiple concurrent projects
- Ensure consistency of RWE outputs across functions and regions
Nice to Have
- Experience in rare disease or CNS disorders
- Prior work in a biotech or pharmaceutical company
- Familiarity with FDA and EMA real world evidence guidance
- Direct experience with patient-reported outcome instruments
- Knowledge of managed care and reimbursement landscapes
Compensation
Competitive hourly rate
Work Arrangement
Remote
Team
Cross-functional team including medical affairs, clinical development, and market access
Therapeutic Focus
Neurodegenerative diseases, with an emphasis on amyotrophic lateral sclerosis (ALS)
Project Duration
Contract position with potential for extension based on project needs
Not applicable
