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Statistical Programmer
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
G528+2M Dolores, Tolima, Colombia
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Description

**Company Description** 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. **Job Description** 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. **Qualifications** * 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.

Source:  indeed View original post
Valentina Rodríguez
Indeed · HR

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