Provide expert oversight of SDTM programming activities from study start‑up through database lock and regulatory submission
Lead or review the development of submission‑ready CDISC SDTM packages, including aCRFs, define.xml, and cSDRGs
Review and contribute to trial set‑up documentation, including data transfer agreements, metadata, and trial design specifications
Create or review SDTM mapping specifications for internal and external data sources
Generate or oversee the creation of SDTM datasets using standardized conversion frameworks and utilities
Ensure high-quality, compliant datasets, including Pinnacle 21 review, readiness for interim analyses, medical review, and final lock
Program or oversee data quality checks and review reports to support Data Management and study teams
Maintain regulatory awareness, ensuring SDTM deliverables meet FDA, PMDA, and global submission requirements
Act as a subject matter expert across CDISC standards (SDTM, CDASH, controlled terminology, define.xml)
Support the development and implementation of programming standards within the organisation
At senior level: mentor junior or flexible resources and provide leadership or coordination of support teams where required

Bachelor’s degree (or higher) in Computer Science, Data Science, Mathematics, or a related scientific discipline (or equivalent experience)
Strong clinical programming background with hands-on trial experience
Expert knowledge of SAS programming within a clinical research environment
Advanced expertise in CDISC SDTM, including aCRFs, define.xml, and cSDRGs
Deep understanding of clinical data structures (SDTM and working knowledge of ADaM)
Experience working in global, cross-functional clinical research teams
Comfortable operating in a fast-paced, matrixed FSP environment
Strong organisational, communication, and stakeholder management skills
Project oversight or coordination experience is highly desirable.

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Clinical Programmer, Advanced

Key skills