Senior Statistical Programmer (SAS)

Location: Remote within Argentina; Buenos Aires, Argentina

Company

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

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 and support SDTM and ADaM specifications.
• Produce pooled datasets, BIMO outputs, define.xml files, Reviewer's Guides, and SDSP deliverables.
• Lead study teams or small programming project teams.
• Work with colleagues to understand requirements and solve clinical data and regulatory submission problems.

Requirements

• Remote work from within Argentina is required.
• Master's degree required for Statistics 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.

Nice to have

• Hands-on experience with clinical trials and pharmaceutical development.
• Familiarity with CROs, scientific and clinical terminology, and the drug development process.
• Experience with current ISO 9001 and ISO 27001 standards.

Culture & Benefits

• Full-time employee position with remote work within Argentina.
• Collaborative and inclusive work environment.
• Opportunity to contribute to clinical research and regulatory submission projects.
• CV must be submitted in English.