Principal Biostatistician – Oncology

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Fortrea

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 complex studies such as NDA submissions or multi-protocol programs, coordinating activities across locations. • Perform project management activities including resource planning, timelines, and milestone management. • Serve as DMC Support Statistician, developing Charters and attending DMC Meetings. • Lead development of Statistical Analysis Plans, perform senior reviews of plans developed by others. • Conduct statistical review of TFLs for complex studies prior to delivery. • Review study-specific specifications. • Provide mentoring and training to less experienced staff. • Present knowledge at seminars and external meetings. • Attend bid defense meetings for complex studies. • Represent the department during audits.

🎯 Requirements

• Bachelor’s degree. • 8+ years of experience or an equivalent combination of education or experience. • Ability to program in one or more statistical software packages (SAS®). • Proficiency in SAS including use of various statistical procedures (non-parametric analysis, linear and non-linear models, categorical data, survival analysis). • Proven ability to effectively communicate statistical concepts. • Good knowledge of the overall clinical trial process. • Competence in preparation of Statistical Analysis Plans, analysis, reporting across a variety of trials. • Preferred: Master’s degree in Biostatistics or related field.

🏖️ Benefits

• Competitive Compensation: We offer a competitive salary package, comprehensive benefits, and a rewarding bonus structure. • Life-Style: Flexibility to work remotely from anywhere, promoting a healthy work-life balance.

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