Biostatisticien principal FSP, RWE

IQVIA seeks a senior biostatistician to provide statistical support for real-world evidence drug development studies. The role involves designing analyses, managing health outcomes research, and collaborating with multidisciplinary teams across regulatory submissions and health technology assessments.

Responsibilities

• Serve as statistical lead on real-world evidence and health outcomes studies with multidisciplinary teams
• Develop statistical analysis plans and write study protocols, analyses, and high-quality research reports
• Select and implement appropriate analytical methods including statistical and machine learning models
• Leverage administrative claims, EMR, registry, and real-world data to recommend optimal analyses
• Communicate findings to internal and external stakeholders and maintain rigorous data quality standards

Requirements

• PhD in statistics, biostatistics, or related field with 5+ years professional experience
• Advanced SAS programming expertise for complex analytical tasks and propensity score matching
• Demonstrated experience analyzing secondary data from claims, EMR, and disease registries
• Deep knowledge of real-world evidence databases and health outcome evaluation methodologies
• Understanding of ICH GCP, ICH E9 guidelines, and international regulatory/HTA requirements
• Proficiency with LOINC codes and ability to develop phenotype algorithms and surrogate endpoints