Principal Biostatistician

March 26

Apply Now

Receive Emails with Similar Jobs

Fortrea

WebsiteLinkedInAll Job Openings

Fortrea is a clinical research organization (CRO) with over 30 years of experience dedicated to accelerating the development of life-changing treatments by providing comprehensive clinical solutions for biopharma and MedTech companies. They offer a range of services including clinical trial management, pharmacology services, and regulatory strategy, all designed around the needs of their clients. Fortrea's mission is to put patients at the center of their work, aiming to bring innovative therapies to market faster through tailored, data-driven approaches.

clinical research • clinical trials

10,000+ employees

💊 Pharmaceuticals

📋 Description

• As an experienced Principal Biostatistician in sponsor-dedicated Flexible Solutions business unit, develop and review Statistical Analysis Plans • Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs • Perform project management activities including resource planning, timelines and milestone management • Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings • Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans • 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 • Preparation and review of randomization specifications and generation of randomization schedules • Provide mentoring and training to less experienced staff; provide direction and review work • 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 • 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 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 • 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

🏖️ Benefits

• Highly competitive compensation packages • Various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances • A genuine work life balance • Flexibility in working hours • A thorough onboarding with support from your personal mentor • Excellent training and career development opportunities • Strong support from your Fortrea Line Manager and team, as well as over 19,000 colleagues worldwide