Senior or Principal Statistical Programmer

Job Description

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.

Are you interested in this position?

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