Principal Biostatistician
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Job Description
Principal Biostatistician leading statistical strategy, analyses, and regulatory delivery for Fortrea’s global clinical-trial programs. Mentoring statisticians and advising multidisciplinary teams across complex CRO studies.
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 quality of statistical outputs
- Provide oversight of statistical analyses, Tables, Figures & Listings (TFLs), and study reporting
- Collaborate closely with cross-functional teams and act as a key statistical advisor
- 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
Requirements:
- Advanced degree (MSc/PhD) in Statistics, Biostatistics, or related field
- Significant experience as a Lead/Principal Biostatistician in CRO, biotech, or pharma
- Strong knowledge of statistical methods for clinical trials and regulatory requirements (FDA/EMA)
- Proficiency in SAS, including advanced procedures
- Solid experience with CDISC standards (SDTM, ADaM, TFLs)
- Ability to communicate complex statistical concepts to diverse stakeholders
- Strong organizational skills, attention to detail, and collaborative mindset
- Fluent in English
Benefits:
- Strong career development and growth opportunities
- Competitive compensation and comprehensive benefits
- Flexible, remote-friendly working environment
- Supportive, collaborative team culture
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