Senior Statistical Programmer (SAS)

Location: Remote within any location in Mexico

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device industries with clinical 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 SDTM and ADaM specifications and support regulatory submission activities.
• Produce pooled datasets, BIMO outputs, define.xml files, Reviewer's Guides, and SDSP materials.
• Lead studies or small statistical programming project teams.
• Collaborate with colleagues to understand requirements and solve programming and data-related problems.

Requirements

• Master's degree in statistics or a related field.
• At least 5 years of experience in statistical programming or a similar field.
• Advanced experience with SAS Base, SAS Macros, and clinical trial database programming.
• Advanced knowledge of SDTM, ADaM, E-Submission Standards, ICH, 21 CFR Part 11, FDA, and GCP requirements.
• Strong scientific, problem-solving, organizational, and communication skills.
• Proficiency with Microsoft Office applications.

Nice to have

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

Culture & Benefits

• Full-time employee position with remote work from Mexico.
• Supportive, collaborative, and inclusive work environment.
• Opportunity to contribute to clinical research and regulatory submission projects.
• hirify.global is a Great Place to Work certified organization with a global presence across four continents.