Trialt is expanding its Statistical Programming team to support international Phase I-IV clinical trials across a range of therapeutic areas. Our programmers work on projects for pharmaceutical, biotechnology, medical device and CRO clients across the US and Europe. Depending on the project and individual experience, you may join a client-dedicated assignment or work within a full-service biometrics team. Project assignments are based on your experience, expertise and current business needs.
What You Will Do
• Develop and validate SDTM and ADaM datasets.
• Produce and independently QC tables, listings and figures.
• Work with protocols, SAPs, dataset specifications and mock shells.
• Review SAS logs and investigate programming or data discrepancies.
• Support the preparation and QC of submission-related deliverables.
• Follow project-specific and company programming standards.
• Maintain clear documentation and provide regular progress updates.
• Collaborate with statistical programmers, biostatisticians, data managers and project teams.
Required Qualifications
• At least 2 years of statistical programming experience in clinical research.
• Good SAS programming skills, including DATA Step, PROC SQL and SAS Macro Language.
• Practical experience with SDTM, ADaM and/or TLF programming.
• Working knowledge of CDISC standards and clinical trial data.
• Understanding of production, independent validation and QC processes.
• Ability to work with programming specifications and study documentation.
• Strong attention to detail and ability to meet agreed timelines.
• English at Intermediate level or higher.
Strong Pluses
• Experience with both SDTM and ADaM.
• Experience using Pinnacle 21 or similar validation tools.
• Familiarity with regulatory submission deliverables.
• Experience with R or Python.
• Previous experience in an international CRO, FSP or sponsor environment.
