Principal Biostatistician

🕒 August 14

⏰ Full Time

🔮 Lead

đŸ§Ș Clinical Research

Where this job comes from

Posted on Fortrea's careers page ↗Fortrea's careers page, not through a job board

First seen by Remote Rocketship August 14

Still open on Fortrea's site. Checked 10 hours ago.

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Logo of Fortrea

Fortrea

10,000+ employees

đŸ„ Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare ‱ Biotechnology ‱ Pharmaceuticals

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

đŸ–ïž 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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