Statistical Programmer II (Clinical Research)

TL;DR

Statistical Programmer II (Clinical Research): Generating tables, listings, and graphs from clinical trial databases using SAS with an accent on SDTM and ADaM standards. Focus on ensuring compliance with E-Submission guidelines, ICH, and FDA regulations to support complex regulatory submissions.

Location: Must be based in South Africa (Home Based)

Company

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

What you will do

• Generate tables, listings, and graphs from clinical trial databases using SAS.
• Utilize System Development Life Cycle (SDLC) for programming deliverables.
• Write specifications for SDTM standards and ensure compliance with ADaM standards.
• Pool data sets for regulatory submissions.
• Prepare BIMO outputs, define.xml, Reviewer's Guides, and SDSP.
• Collaborate as an active member of the project team.

Requirements

• Master's degree required for all Statistics roles.
• Minimum of 3 years of experience in Statistical Programming or a similar field.
• Expert knowledge of scientific principles and clinical trial data.
• Proficiency in SAS programming, SAS Base, and SAS Macros.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Must be based in South Africa for this home-based role.

Nice to have

• Hands-on experience with clinical trial and pharmaceutical development.
• Familiarity with ISO 9001 and ISO 27001 standards.

Culture & Benefits

• Great Place to Work certified organization.
• Industry-leading employee retention rates.
• Collaborative and inclusive global work environment.
• Supportive team focused on scientific excellence.