Statistical Programmer at Yuxi Global

Perímetro Urbano Medellín, Antioquia, Colombia -

Full Time

Start Date

Immediate

Expiry Date

26 Jan, 26

Salary

0.0

Posted On

28 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Programming, CDISC, SDTM, ADaM, TFL Programming, SAS, Regulatory Submissions, Data Management, Biostatistics, Documentation, Mentoring, Collaboration, Quality Control, XML, Jira, Confluence

Industry

IT Services and IT Consulting

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.

Responsibilities

The Statistical Programmer will lead programming activities for clinical trial data preparation, analysis, and reporting. This includes developing and maintaining datasets in accordance with CDISC standards and generating high-quality Tables, Listings, and Figures.