Principal Statistical Programmer

Trialt; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Trialt is seeking an experienced Senior Statistical Programmer to lead programming across one or more clinical studies, ensuring SDTM/ADaM deliverables meet CDISC and regulatory standards. You will plan timelines, allocate tasks, and drive quality while mentoring junior programmers.

The role is fully remote for US-based projects with international collaboration across Europe. Strong SAS/CDISC expertise and leadership experience are required to manage submissions and review complex outputs.

Qualifications

• Extensive statistical programming experience within clinical research.
• Advanced SAS programming skills and strong knowledge of CDISC SDTM and ADaM standards.
• Experience producing and independently reviewing SDTM, ADaM and TLF deliverables.
• Experience leading programming activities at 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 at Upper-Intermediate level or higher.

Responsibilities

• 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 regulatory compliance.
• Maintain traceability from source data through SDTM/ADaM to outputs.
• Prepare and review Define-XML, aCRF, SDRG, ADRG and validation reports.
• Investigate and resolve 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 with biostatistics, data management, medical writing and project management.

Job description

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

• 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, aCRF, SDRG, ADRG 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 within 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 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 at Upper-Intermediate level or higher.

Preferred Qualifications

• Experience leading programming activities across multiple studies or submissions.
• Experience with Define-XML, aCRF, SDRG and ADRG.
• Experience supporting FDA, EMA or other regulatory submissions.
• Experience with R or Python.
• Previous experience in an international CRO, FSP or sponsor environment.

Recruitment Process

We keep the recruitment process practical and straightforward.

• A short introductory screening call.
• One or two interview rounds, depending on the project. For client-dedicated assignments, the second round may be conducted by the client.

Working Model

• Fully remote position.