Senior Statistical Programmer (SAS)

TL;DR

Senior Statistical Programmer (SAS): Developing tables, listings, and graphs from clinical trial databases using SAS with an accent on E-Submission standards and regulatory compliance. Focus on implementing SDTM and ADaM standards, leading small programming teams, and ensuring adherence to FDA and GCP requirements.

Location: Remote (Must be legally authorized to work in the U.S. for any employer; no visa sponsorship or transfers provided)

Company

hirify.global is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries.

What you will do

• Generate tables, listings, and graphs from clinical trial databases using SAS.
• Implement the System Development Life Cycle (SDLC) for all programming deliverables.
• Develop and maintain SDTM and ADaM standards, including writing detailed specifications.
• Manage pooling of data sets for regulatory submissions and produce BIMO outputs.
• Lead study or small programming project teams to ensure high-quality deliverables.
• Ensure compliance with ICH, 21 CFR Part 11, and ISO 9001:2000 requirements.

Requirements

• Master's degree is required for all Statistics roles.
• Minimum of 5 years of experience in Statistical Programming or a similar field.
• Advanced mastery of SAS programming, SAS Base, and SAS Macros.
• Expert knowledge of E-Submission Standards, Guidelines, and Regulations.
• Proficiency with MS Office applications.
• Must be legally authorized to work in the U.S.

Nice to have

• Hands-on experience with pharmaceutical development and clinical trials.
• Familiarity with current ISO 9001 and ISO 27001 standards.
• Understanding of CRO operations and drug development processes.

Culture & Benefits

• Great Place to Work certified organization.
• Collaborative and inclusive work environment with a high employee retention rate.
• Global footprint across four continents with a supportive and innovative team.