Statistical Programmer

Reposted 9 Days Ago
Be an Early Applicant
Hiring Remotely in Medellín, Antioquia
In-Office or Remote
Mid level
Information Technology
The Role
The Statistical Programmer will perform programming for clinical trial data, develop datasets according to CDISC standards, and collaborate across teams. Responsibilities include mentoring junior programmers and ensuring compliance in deliverables.
Summary Generated by Built In
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

  • 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.

Top Skills

.Net
Confluence
Git
JIRA
Azure
Node.js
Power BI
R
React
SAS
Ux/Ui
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The Company
HQ: Miami, Florida
140 Employees
Year Founded: 2005

What We Do

Yuxi Global (powered by Veritas Automata) is a leading people and technology force multiplier dedicated to empowering businesses in achieving their digital goals since 2005. We specialize in providing comprehensive solutions, including turnkey enterprise-grade application, managed development teams and strategic consulting via our Veritas Automata Services Team, tailored to meet the unique requirements of our clients. We are headquartered in the United States and operate with a robust team of over 150 skilled IT professionals located strategically in North and South America, including the United States, Colombia, Mexico, Brazil, and Costa Rica.

With a proven track record of success and nearly 100 clients we’ve partnered with, Yuxi Global has played a vital role in enabling numerous life science, transportation, manufacturing, and supply companies to advance their digital solutions. We leverage cutting-edge technologies utilizing Microsoft Azure/.Net, Node.js, React and UX/UI design to create impactful solutions that drive business growth and captivate your audiences.

Our team of experienced professionals works closely with clients to understand their specific needs and objectives. We collaborate to develop innovative strategies and deliver tailored software solutions that not only meet immediate requirements but also pave the way for long-term success.

At Yuxi Global, we are committed to delivering excellence in every project we undertake. We strive to establish strong partnerships with our clients, fostering open communication and transparency throughout the development process. Our goal is to provide exceptional value by delivering high-quality solutions, on time and within budget.

Partner with Yuxi Global (powered by Veritas Automata) to unlock the full potential of your digital product. Contact us today to discover how our expertise and comprehensive services can propel your business forward.

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