Principal Biostatistician

About the role

Fortrea is looking for a Principal Biostatistician to lead the design, analysis and delivery of complex clinical trials within its Full Service team. The role supports global programs from study design through regulatory submissions and beyond, partnering with multidisciplinary stakeholders and providing strategic statistical leadership.

Key responsibilities

• Lead statistical strategy and delivery for complex studies and programs, including submissions and multi-protocol work
• Develop and review Statistical Analysis Plans and ensure the quality of statistical outputs
• Oversight of statistical analyses, Tables, Figures & Listings (TFLs) and study reporting
• Act as a key statistical advisor to cross-functional teams
• Support regulatory interactions, publications and post hoc analyses
• Contribute to study design, protocols and randomization planning
• Mentor junior statisticians and provide technical leadership
• Represent Biostatistics in client interactions, bid defenses and audits

Required profile

• Advanced degree (MSc/PhD) in Statistics, Biostatistics or a related field
• Significant experience as a Lead/Principal Biostatistician in a CRO, biotech or pharma setting
• Strong knowledge of statistical methods for clinical trials and regulatory requirements (FDA/EMA)
• Fluent in English

Required skills

• SAS proficiency, including advanced procedures
• Solid experience with CDISC standards (SDTM, ADaM, TFLs)
• Ability to explain complex statistical concepts to diverse stakeholders

What we offer

• Work on complex, high-impact global studies
• Career development and growth opportunities
• Competitive compensation and comprehensive benefits
• Flexible, remote-friendly working environment
• Supportive, collaborative team culture