Clinical Data Management & Analysis SME (AI)

Location: Hybrid work from the Austin hub, United States

Company

hirify.global is a Healthtech company using AI to accelerate drug development and improve patient access to treatments.

What you will do

• Own SDTM and ADaM mapping specifications for data flowing through Aika.
• Define and maintain clinical data standards governance across the data team.
• Review and validate data structures for submission readiness and audit defensibility.
• Partner with Data Engineering and Architecture to embed standards into pipelines across patient data sources and EDC platforms.
• Track CDISC updates and FDA/EMA regulatory expectations.
• Train and support team members in applying clinical data standards.

Requirements

• 5+ years of dedicated CDISC, SDTM, or ADaM experience in standards programming, mapping, or governance.
• Deep hands-on knowledge of SDTM and ADaM implementation guides.
• Experience ensuring regulatory-facing clinical data is submission-ready.
• Excellent attention to detail and documentation discipline.
• Excellent written and verbal English communication skills.

Nice to have

• CDISC certification.
• Experience with USDM or protocol digitalisation standards.
• Experience working with AI/ML teams to translate standards into automated pipelines.

Culture & Benefits

• International, collaborative team focused on improving clinical research and patient outcomes.
• Hybrid work model.
• MacBook provided.
• Benefits package supporting employees and their families.
• Medical, dental, and vision insurance options, effective from the start date or shortly thereafter depending on location.
• Company events and a pet-friendly office.