Senior Biostatistician – FSP

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🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $115k - $135k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings. • Perform project management activities for identified projects including resource planning, timelines, and milestone management. • Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff. • Perform complex statistical analyses, quality check statistical analyses developed by other statisticians. • Conduct overall statistical review of TFLs for complex studies prior to client delivery. • Review CRF and other study specific specifications and plans. • May perform sample size calculation for simple studies under the supervision of more senior statistical staff. • Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant. • Provide statistical input and review of the CSR for medium complexity studies. • Preparation and review of randomization specifications and generation of randomization schedules. • Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department. • Present and share knowledge at team meetings and/or at monthly seminars. • Attend bid defense meetings for medium complexity studies in order to win new business. • Represent the department during project-driven client audits. • All other duties as needed or assigned.

🎯 Requirements

• Bachelor’s degree required. • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. • Must have an excellent command of the English language, both oral and written. • 5+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job. • Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. • SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis. • Ability to effectively communicate statistical concepts. • A good knowledge of the overall clinical trial process. • Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc.

🏖️ Benefits

• Medical • Dental • Vision • Life • STD/LTD • 401(K) • ESPP • Paid time off (PTO) • Flexible time off (FTO) • Company bonus where applicable