Fortrea
10,000+ employees
🏥 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.
Senior Statistical Programmer – Oncology
🕒 December 7, 2025
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Fortrea
10,000+ employees
🏥 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
• Perform programming activities for oncology clinical trials, ensuring quality, accuracy, compliance with study timelines, and regulatory standards • Review SAPs and TFL shells from a programming perspective and provide technical input to optimize oncology analyses • Advise on the design and development of complex TFL shells and statistical outputs for oncology studies • Develop and/or lead specifications for SDTM and ADaM datasets • Develop and maintain SAS programs to create SDTM and ADaM datasets and generate Tables, Figures, and Listings (TFLs) • Perform thorough quality control checks • Produce and validate Define.xml/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides • Contribute to regulatory submission packages and responses to regulatory and client audits • Identify, propose, and implement process improvements to enhance programming efficiency, quality, and standardization • Stay up to date on industry standards, global regulatory requirements, Fortrea SOPs, and CDISC developments relevant to oncology data
🎯 Requirements
• Degree in a relevant field such as Mathematics, Life Sciences, Statistics, or Computer Science • Equivalent vocational training and/or significant professional experience in clinical statistical programming may be considered • Minimum of 4 years’ hands-on experience in oncology clinical trials • Proven experience with SAS programming (Base SAS, SAS Macros, SAS/STAT) • Ability to debug complex programs • Strong practical knowledge of CDISC standards (SDTM, ADaM) • Experience generating safety and efficacy reporting outputs for Phase III oncology studies • Experience with regulatory submission deliverables, including Define.xml, ARM, and reviewers’ guides • Strong organizational skills with an autonomous yet collaborative working style • A curious and analytical mindset, with a keen eye for detail and quality • Business fluency in English, both spoken and written
🏖️ Benefits
• 100% home-based work option • Option to work from a local office in the employee's home country
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