Senior Software Engineer – React Native
Kraken Digital Asset Exchange
AndroidiOSJavaJavaScriptKotlinNext.jsObjective-CReactReact NativeTypeScript
Senior/Principal Statistical Programmer – Oncology
Fortrea
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇪🇺 Anywhere in Europe
Visit company websiteJob 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
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 is required
- 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
- Experience with regulatory submission deliverables, including Define.xml, ARM, and reviewers’ guides
- Business fluency in English, both spoken and written
Benefits
- Flexible work arrangements
- Professional development opportunities
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 outputsprocess improvementsdata specifications
Soft skills
communicationadvisoryproblem-solvingattention to detailorganizational skills
