Responsibilities
- Design and execute statistical analyses for PRO data in standalone studies
- Conduct post-hoc analyses of clinical trial data to uncover additional value in study treatments
- Translate complex statistical results into evidence that meets regulatory, clinical, and payer expectations
- Serve as a trusted advisor to clients and stakeholders on PRO statistical strategies within drug development pipelines
- Design studies using non-interventional data or devise statistical approaches to analyze PROs in interventional studies, enabling robust and meaningful insights.
- Develop detailed statistical analysis plans, execute data analyses, interpret findings, and prepare clear, comprehensive reports.
- Conduct post-hoc analyses of clinical trial data to identify additional treatment benefits or insights related to PROs.
- Compile and author statistical sections of COA dossiers, integrating evidence to support regulatory and market access submissions.
- Maintain strong Sponsor relationships by delivering scientifically rigorous analyses designed to meet client and program needs, balancing methodological precision with practical decision-making.
Requirements
- proven track record in life sciences consulting
- expertise in applying advanced statistical methods to patient-reported outcomes (PROs)
Nice to Have
- experience designing and analyzing Discrete Choice Experiments (DCE) and other stated-preference methodologies (e.g., Best-Worst Scaling, Conjoint Analysis) to quantify patient preferences and inform product development and market access strategies
Work Arrangement
Hybrid
