Senior or Principal Statistical Programmer - Oncology - Sponsor Dedicated

**This role is for upcoming future opportunities that may arise at Fortrea.** ----------------------------------------------------------------------------- As a **Senior or Principal Statistical Programmer** in our sponsor-dedicated **Flexible Solutions** business unit, you will be central to the successful delivery of **complex global oncology clinical trials** (Phases I–III) for some of the world’s most renowned and innovative pharmaceutical companies. In this role, you will contribute to the development of new and life-changing oncology therapies by developing and validating **SAS programs** for data analysis and reporting, supporting submissions, regulatory responses, publications, and post-hoc requests. Your expertise will directly impact the advancement of oncology treatments and the lives of thousands of patients around the world. You can be **100% home-based**, or if you prefer, work from one of our local offices in your home country. **Your Responsibilities** * 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. **Your Profile** * 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** is **required**. * Proven experience with SAS programming (Base SAS, SAS Macros, SAS/STAT) and ability to debug complex programs. * Strong practical knowledge of CDISC standards (SDTM, ADaM) and 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. Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).