Statistical Programmer / Senior / Principal Statistical Programmer – Clinical Trials | SAS, SDTM & ADaM
TrialtTrialt is expanding its Statistical Programming team and is hiring for three positions:
1. Statistical Programmer / Analyst
2. Senior Statistical Programmer
3. Principal Statistical Programmer
About the Opportunity
Trialt supports international Phase I-IV clinical trials across a range of therapeutic areas. Our programmers work with pharmaceutical, biotechnology, medical device, and CRO clients throughout the United States and Europe.
We are hiring statistical programmers at multiple experience levels. Depending on your background and current project needs, you may join a client-dedicated assignment or work within a full-service biometrics team. Candidates will be considered for the position that best matches their qualifications and expertise.
Statistical Programmer / Analyst
What You Will Do:
• Develop and validate SDTM and ADaM datasets.
• Produce and independently perform quality control for tables, listings, and figures.
• Work with protocols, statistical analysis plans, dataset specifications, and mock shells.
• Review SAS logs and investigate programming or data discrepancies.
• Support the preparation and quality control 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 two 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 quality control processes.
• Ability to work with programming specifications and study documentation.
• Strong attention to detail and the ability to meet agreed timelines.
• English proficiency at the Intermediate level or higher.
Preferred Qualifications
• 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.
______________________________________________
Senior Statistical Programmer
What You Will Do
• Independently develop and validate SDTM and ADaM datasets.
• Produce and perform quality control for complex tables, listings, and figures.
• Interpret protocols, statistical analysis plans, 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 in 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 quality control.
• 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, statistical analysis plans, specifications, and study documentation.
• Ability to manage programming activities for an assigned study or workstream.
• Strong communication, organizational, and problem-solving skills.
• English proficiency at the Upper-Intermediate level or higher.
Preferred Qualifications
• Previous experience as a Lead Programmer or readiness to take ownership of programming activities.
• Experience with Define-XML, annotated CRFs, SDRGs, and ADRGs.
• 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.
______________________________________________
Principal Statistical Programmer
What You Will Do
• Lead statistical programming activities across one or more clinical studies.
• Oversee the development and validation of SDTM, ADaM, and TLF deliverables.
• Plan programming work, estimate timelines, and coordinate task allocation.
• Review complex deliverables and ensure compliance with project, CDISC, and regulatory requirements.
• Maintain traceability from source data through SDTM and ADaM to final statistical outputs.
• Support the preparation and review of Define-XML, annotated CRFs, SDRGs, ADRGs, and validation reports.
• Investigate and resolve complex programming, data, and submission-readiness issues.
• Lead client-facing meetings and technical discussions.
• Monitor project quality, timelines, risks, and programming status.
• Mentor programmers and provide technical leadership.
• Collaborate closely with biostatistics, data management, medical writing, and project management teams.
Required Qualifications
• Extensive statistical programming experience in clinical research.
• Advanced SAS programming skills and strong knowledge of CDISC SDTM and ADaM standards.
• Extensive experience producing and independently reviewing SDTM, ADaM, and TLF deliverables.
• Experience leading programming activities at the study or project level.
• Strong understanding of regulatory submission requirements and end-to-end traceability.
• Experience reviewing submission documentation and resolving Pinnacle 21 findings.
• Ability to plan work, estimate timelines, oversee quality, and manage programming risks.
• Strong client-facing communication and technical leadership skills.
• Ability to mentor programmers and make independent technical decisions.
• English proficiency at the Upper-Intermediate level or higher.
Preferred Qualifications
• Experience leading programming activities across multiple studies or submissions.
• Experience with Define-XML, annotated CRFs, SDRGs, and ADRGs.
• Experience supporting FDA, EMA, or other regulatory submissions.
• Experience with R or Python.
• Experience developing programming standards, reusable tools, or automation.
• Previous experience in an international CRO, FSP, or sponsor environment.
______________________________________________
Recruitment Process
The recruitment process begins with a brief screening call, followed by one or two rounds of interviews based on the position level and potential project assignment. For client-dedicated assignments, an interview may be conducted by the client.
Position Details
• Fully remote
• Full-time
• Long-term opportunity
We welcome applications from statistical programmers at any of the three experience levels. If your background aligns with one of these opportunities, we invite you to apply.