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.
Top Skills
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.
Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
