Senior Statistical Programmer (SAS)

Location: Remote within any location in Colombia

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device industries with complex trial data and regulatory submission expertise.

What you will do

• Generate tables, listings, and graphs from clinical trial databases using SAS.
• Develop programming deliverables in accordance with the System Development Life Cycle.
• Prepare clinical trial and regulatory submission outputs, including pooled datasets, BIMO outputs, define.xml, Reviewer's Guides, and SDSP.
• Write and support specifications for SDTM and ADaM standards.
• Lead study teams or small statistical programming projects.

Requirements

• Master's degree required for statistical roles.
• At least 5 years of experience in statistical programming or a similar field.
• Advanced SAS programming skills, including SAS Base and SAS Macros.
• Advanced knowledge of SDTM, ADaM, e-submission standards, guidelines, and regulations.
• Knowledge of ICH, 21 CFR Part 11, FDA, GCP, ISO 9001, and ISO 27001 requirements.
• Strong scientific knowledge, problem-solving ability, organization, communication, and collaboration skills.

Nice to have

• Hands-on experience with clinical trials and pharmaceutical development.
• Basic understanding of CROs, scientific and clinical terminology, and the drug development process.

Culture & Benefits

• Full-time remote employment from anywhere in Colombia.
• Supportive, collaborative, and inclusive work environment.
• Work with pharmaceutical, biotech, and medical device companies on clinical research projects.
• Opportunity to contribute to complex trial data and regulatory submission work.