Software Engineer

• 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

Senior/Principal Statistical Programmer – Oncology

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