About the Role
Trialt is expanding its Statistical Programming team to support international Phase
What You Will Do
• Independently develop and validate SDTM and ADaM datasets.
• Produce and QC complex tables, listings and figures.
• Interpret protocols, SAPs, dataset specifications and mock shells.
• Take ownership of programming activities for an assigned study or workstream.
• Review deliverables produced by other programmers and provide technical guidance.
• Investigate data issues, SAS log findings and validation findings.
• Support submission deliverables and study documentation.
• Estimate tasks, monitor timelines and communicate project status.
• Participate in client meetings and technical discussions.
• Collaborate with biostatisticians, data managers, medical writers and project teams.
Required Qualifications
• Solid statistical programming experience within clinical research.
• Strong SAS programming skills, including DATA Step, PROC SQL and SAS Macro Language.
• Hands-on experience with SDTM, ADaM and TLF production and QC.
• Strong working knowledge of CDISC standards and controlled terminology.
• Understanding of traceability from source data through SDTM and ADaM to statistical outputs.
• Ability to work independently with protocols, SAPs, specifications and study documentation.
• Ability to manage programming activities for an assigned study or workstream.
• Strong communication, organisation and problem-solving skills.
• English at Upper-Intermediate level or higher.
Strong Pluses
• Previous experience as a Lead Programmer or readiness to take programming ownership.
• Experience with Define-XML, aCRF, SDRG and ADRG.
• Experience using Pinnacle 21 or similar validation tools.
• Experience supporting regulatory submissions.
• Experience with R or Python.
• Previous experience in an international CRO, FSP or sponsor environment.
Working Model
• Fully remote position.
• Full-time engagement.
• Long-term cooperation.