Real World Evidence Lead

Responsibilities

• Set and lead the strategy for real-world and observational evidence generation to support clinical adoption and regulatory decision points.
• Lead the implementation of real-world evidence studies, including protocol development and reporting for disease understanding studies.
• Oversee post-marketing evidence strategy, including safety/effectiveness studies and registries.
• Establish and lead research plans with external collaborators such as CROs, academia, and data partners.
• Define and oversee secondary data analysis strategies using clinical and real-world data to ensure analytic rigor.
• Synthesize real-world evidence to provide recommendations for internal governance and drive external scientific dissemination through manuscripts and presentations.
• Serve as a strategic partner to Commercial, Market Access, and Regulatory teams.

Requirements

• PhD, ScD, or DrPH in Epidemiology or a related field (e.g., Health Services Research, Statistics, or Pharmaceutical Sciences).
• 8-10 years of epidemiologic research experience within the pharmaceutical industry.
• Deep expertise in observational study design and advanced analytic methods.
• Strong understanding of healthcare data ecosystems and standards, including HL7, FHIR, and ICD-10.
• Extensive experience working with EMR and claims data.
• Familiarity with data governance and privacy requirements, such as GDPR and HIPAA.
• Proven ability to lead high-stakes engagement with regulators and ethics bodies.

Preferred Qualifications

• Experience in rare disease epidemiology or genetic epidemiology.
• Experience working with small patient populations, registries, and novel endpoints.

About the Company

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. We are dedicated to delivering innovative treatments to patients and families around the world.