Senior Statistical Programmer – Oncology

Fortrea

full-time

Posted on: 10/15/2025

Location Type: Remote

Location: Remote • 🇧🇷 Brazil

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Senior

About the role

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.

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

Tip: use these terms in your resume and cover letter to boost ATS matches.

SAS programmingBase SASSAS MacrosSAS/STATSDTMADaMquality controlstatistical outputsprogramming activitiesprocess improvements

organizational skillscollaborative working styleautonomous working style