Fortrea

Senior Statistical Programmer – Oncology

Fortrea

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇧🇷 Brazil

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Job Level

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.

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

Applicant Tracking System Keywords

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

Hard skills
SAS programmingBase SASSAS MacrosSAS/STATSDTMADaMquality controlstatistical outputsprogramming activitiesprocess improvements
Soft skills
organizational skillscollaborative working styleautonomous working style