Principal Biostatistician

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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

• Competitive compensation and comprehensive benefits • Flexible, remote-friendly working environment • Strong career development and growth opportunities • Supportive, collaborative team culture