Statistical Programmer

The Statistical Programmer will lead key programming activities required for clinical trial data preparation, analysis, and reporting. The role requires expert-level hands-on programming experience, strong CDISC knowledge, and the ability to collaborate across teams while ensuring quality, accuracy, and compliance.

Key Responsibilities

• Perform statistical programming activities to support data analysis, interpretation, and regulatory submissions.
• Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards. Generate high-quality Tables, Listings, and Figures (TFLs) per SAP and study requirements.
• Prepare and maintain programming deliverables including dataset specifications, documentation, reviewer guides, and QC records.
• Mentor and train junior programmers; help elevate programming standards, workflows, and best practices.
• Collaborate across biostatistics, data management, clinical operations, and project management to ensure seamless execution of deliverables.
• May serve as Programming Lead on assigned studies.

• Minimum 6 years of experience as a statistical programmer within clinical trials (pharma, biotech, or CRO).
• Demonstrated proficiency in TFL programming. Strong command of CDISC SDTM and ADaM standards and submission practices.
• Experience preparing regulatory submission documentation and supporting data review.
• High attention to detail, structured communication style, and strong documentation discipline.
• Bachelor’s degree in statistics, computer science, life sciences, mathematics, or related field.

Technical Skills

• SDTM and ADaM dataset development and validation, TFL programming aligned with SAP and regulatory standards
• Define XML and submission documentation, including Pinnacle 21 and reviewer guides, QC processes, including double programming and traceability
• Knowledge of clinical trial data structures for safety and efficacy SAS programming: Advanced proficiency (Base SAS, Macros, PROC SQL, ODS).
• Familiarity with R for statistical computing and visualization (preferred but not required).
• Working knowledge of CDISC tools and associated validation frameworks.
• Experience using Jira, Confluence, or equivalent project management tools (preferred).
• Familiarity with Git or other version control systems.
• Experience working in a regulated environment (GxP, FDA, EMA submission settings).
• Comfort working in Windows and/or Linux command-line environments.

Yuxi Global (powered by Veritas Automata) has been a leading force in empowering Life Sciences companies to achieve their digital goals since 2005.

We specialize in providing comprehensive solutions, including turnkey enterprise-grade application development, managed development teams, staff augmentation, and strategic consulting via our Veritas Automata Services Team. With headquarters in the United States and a team of over 150 skilled IT professionals located throughout North and South America, including the United States, Colombia, Mexico, Brazil, and Costa Rica, we are well-positioned to meet the unique requirements of our clients.

Having partnered with nearly 300 clients, Yuxi Global has played a crucial role in advancing digital solutions for companies in life sciences. Utilizing cutting-edge technologies such as Microsoft Azure, PowerBI, .Net Custom development, Node.JS, React, and UX/UI design, we deliver impactful solutions that drive business growth and captivate audiences.