Position is Fully Remote

Responsibilities:

Epidemiology & Disease Characterization

• Characterize the epidemiology of rare and complex diseases, including:
• Incidence and prevalence
• Patient population estimation and sizing
• Support epidemiologic analyses for regulatory submissions and strategic planning.
• Conduct systematic literature reviews and evidence syntheses.

Develop evidence packages supporting:

• Benefit-risk assessments
• Regulatory briefing documents
• Scientific narratives
• Real-World Evidence Strategy
• Design and interpret real-world evidence (RWE) studies to complement clinical trial findings.
• Support evidence generation strategies in regulatory, lifecycle management, and post-approval settings.
• Translate complex evidence into regulatory-grade scientific insights.

Requirements:

• PhD, MD, or equivalent advanced degree in epidemiology, public health, health outcomes research, biostatistics, or a related discipline.
• 15+ years of experience in epidemiology, evidence generation, or regulatory strategy.
• Demonstrated experience supporting regulatory evidence strategy and scientific document development.
• Strong expertise in real-world evidence methodologies and observational study design.
• Experience with comparative effectiveness research and indirect treatment comparisons.