Principal Biostatistician

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🕒 May 30

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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 complex studies such as New Drug Applications submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings • Perform project management activities for identified projects including resource planning, timelines and milestone management • Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants • Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians • Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery • Review Case Report Form and other study specific specifications and plans • Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant • Preparation and review of randomization specifications and generation of randomization schedules • Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures • Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences • Attend bid defense meetings for complex studies • Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives • Represent the department during audits.

🎯 Requirements

• Degree in a relevant field such as statistics, computer sciences, etc. • Solid experience of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company • 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 • Proven professional experience with SDTMs, ADaM datasets and TFLs • Proven ability to effectively communicate statistical concepts • A good knowledge of the overall clinical trial process • Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials • Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail • Business fluency in English – both verbal and written – is a must.

🏖️ Benefits

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