FSP Principal Biostatistician, Medical Affairs

IQVIA seeks a Principal Biostatistician to provide statistical analysis support for Phase 2 and 3 clinical trials through an embedded partnership model. The role involves collaborating with cross-functional sponsor teams on study design, analysis planning, and regulatory submissions.

Responsibilities

• Establish project objectives and timelines with multi-disciplinary teams
• Author statistical analysis plans and interpret study results
• Program or validate statistical outputs and review reports for accuracy
• Support exploratory analyses and contribute to publications and presentations
• Provide guidance to statistical programmers on analysis planning and execution

Requirements

• PhD in Statistics, Biostatistics, or related field with 5+ years industry experience, OR MS with 7+ years experience
• Minimum 3 years Phase 2/3 clinical trial experience
• Proficiency in SAS or R for efficacy, safety analyses, and data validation
• Knowledge of ICH GCP, ICH E9, and industry standards
• Experience with CDISC standards including SDTM, ADAM, CDASH
• Ability to work independently in fast-paced environment and manage programmers effectively
• Strong written and verbal communication skills

Compensation: $111,000–$309,000 base