Senior or Principal Statistical Programmer - ONCOLOGY - Sponsor dedicated
Full-timeSenior
Description
<p>As a <b>Senior or Principal Statistical Programmer</b> in our sponsor-dedicated <b>Flexible Solutions</b> business unit, you will be central to the successful delivery of <b>complex global oncology clinical trials</b> (Phases I–III) for some of the world’s most renowned and innovative pharmaceutical companies.</p><p></p><p>In this role, you will contribute to the development of new and life-changing oncology therapies by developing and validating <b>SAS programs</b> for data analysis and reporting, supporting submissions, regulatory responses, publications, and post-hoc requests.</p><p></p><p>Your expertise will directly impact the advancement of oncology treatments and the lives of thousands of patients around the world.</p><p></p><p>You can be <b>100% home-based</b>, or if you prefer, work from one of our local offices in your home country.</p><h1></h1><p><span class="emphasis-2"><b>Your Responsibilities</b></span></p><ul><li><p>Perform programming activities for oncology clinical trials, ensuring quality, accuracy, and compliance with study timelines and regulatory standards.</p></li><li><p>Review SAPs and TFL shells from a programming perspective, providing technical input to optimize oncology analyses.</p></li><li><p>Advise on the design and development of complex TFL shells and statistical outputs for oncology studies.</p></li><li><p>Develop and/or lead the creation of specifications for SDTM and ADaM datasets.</p></li><li><p>Develop and maintain SAS programs to create SDTM and ADaM datasets and generate Tables, Figures, and Listings (TFLs); perform thorough quality control (QC) checks.</p></li><li><p>Produce and validate Define.xml/PDFs, Analysis Results Metadata (ARM), annotated CRFs, and Reviewers’ Guides to support SDTM and ADaM submissions.</p></li><li><p>Contribute to the preparation of regulatory submission packages and responses to regulatory and client audits.</p></li><li><p>Identify, propose, and implement process improvements to enhance programming efficiency, quality, and standardization.</p></li><li><p>Stay up to date on industry standards, global regulatory requirements, Fortrea SOPs, and CDISC developments relevant to oncology data.</p></li></ul><p></p><p><span class="emphasis-2"><b>Your Profile</b></span></p><ul><li><p>Degree in a relevant field such as Mathematics, Life Sciences, Statistics, or Computer Science.</p></li><li><p>Equivalent vocational training and/or significant professional experience in clinical statistical programming may be considered.</p></li><li><p><b>Minimum of 4 years’ hands-on experience in oncology clinical trials</b> is <b>required</b>.</p></li><li><p>Proven experience with SAS programming (Base SAS, SAS Macros, SAS/STAT) and ability to debug complex programs.</p></li><li><p>Strong practical knowledge of CDISC standards (SDTM, ADaM) and experience generating safety and efficacy reporting outputs for Phase III oncology studies.</p></li><li><p>Experience with regulatory submission deliverables, including Define.xml, ARM, and reviewers’ guides.</p></li><li><p>Strong organizational skills with an autonomous yet collaborative working style.</p></li><li><p>A curious and analytical mindset, with a keen eye for detail and quality.</p></li><li><p>Business fluency in English, both spoken and written.</p></li></ul><p></p><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO & Accommodations request here</a><span>.</span></p>