Senior Statistical Programmer – Oncology

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October 15

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Fortrea

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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.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Perform programming activities for oncology clinical trials, ensuring quality, accuracy, and compliance with study timelines and regulatory standards • Review SAPs and TFL shells from a programming perspective, providing 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 the creation of 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 (QC) checks • Produce and validate Define.xml/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides to support SDTM and ADaM submissions • Contribute to the preparation of 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 • Minimum of 4 years’ hands-on experience in oncology clinical trials • Proven experience with SAS programming (Base SAS, SAS Macros, SAS/STAT) • Strong practical knowledge of CDISC standards (SDTM, ADaM) • Experience generating safety and efficacy reporting outputs for Phase III oncology studies • Strong organizational skills with an autonomous yet collaborative working style • Business fluency in English, both spoken and written.

🏖️ Benefits

• 100% home-based option • Work from local offices in your home country