Director HTA Statistics & RWE Methods
$341,120–$341,120 year
On-siteRaritan, New Jersey, United States or Horsham, Pennsylvania, United States
Job Summary
Lead dataset feasibility, protocol development, and study design for indirect treatment comparisons, post hoc trial analyses, and real-world evidence initiatives across the Johnson & Johnson portfolio. Act as key reviewer for the Global RWE Methods Review Board to ensure robust governance and methodological consistency, while synthesizing external case studies to shape internal strategy. Guide advanced statistical analyses aligned with Payer/HTA expectations, including causal inference and surrogate endpoint validations, to support market access and launch strategies. Provide capability building through team training on regulatory requirements and new methodologies, alongside the development of coding libraries and AI/ML analytics platforms. This role spans all therapeutic areas from early development through post-launch, requiring deep expertise in evolving methodologies and secondary data sources.
Required Qualifications
- Postgraduate degree (MSc, PhD) in Biostatistics, Epidemiology, Data Science, Health Economics, or related field
- Minimum 8 years of relevant experience in pharmaceutical, biotech, or consulting environments
- Demonstrated experience in advanced statistical methodologies relevant for Payer/HTA evidence generation including indirect treatment comparisons and RWE
- Deep expertise in clinical trial design and the strengths and limitations of secondary data sources (claims, EMR, registries, surveys)
- Advanced knowledge of statistical methodologies for market access, including indirect treatment comparisons and causal inference approaches
- Strong understanding of methodological standards, regulatory and Payer/HTA frameworks and their application to evidence generation
- Hands-on proficiency in statistical programming (SAS, R)
- Able to organize work into clear project plans with defined milestones, deliverables, and resources
Desired Qualifications
- PhD, PharmD, or MD
- Desirable
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