Principal Biostatistician FSP, RWE

Principal Biostatistician providing statistical leadership for real-world evidence research within a functional service provider model at IQVIA. Role involves designing RWE studies, developing analytical strategies, and supporting regulatory and payer submissions across multiple therapeutic programs.

Responsibilities

• Serve as statistical lead and subject matter expert for RWE, HEOR, and health outcomes studies
• Write statistical analysis plans and develop study protocols aligned with regulatory requirements
• Select and implement analytical methods including statistical and machine learning models
• Leverage real-world data sources and recommend optimal analytical approaches for analysis
• Collaborate with cross-functional teams to establish project goals and support RWD strategy

Requirements

• Ph.D. in Statistics, Biostatistics, or related field with 5+ years industry experience
• Expert-level SAS programming for complex analyses including propensity score matching
• Demonstrated experience leading secondary data analysis with claims and EMR datasets
• In-depth knowledge of RWE databases, CDISC standards, and regulatory/HTA requirements
• Proficiency in LOINC codes, healthcare cost analysis, and clinical endpoint surrogate algorithms
• Strong ability to lead multiple projects and communicate complex findings to stakeholders