Principal Statistical Programmer SP4
P-Product · UA ·
- Work mode
- Remote
- Seniority
- Principal
Lead statistical programming for clinical trials, overseeing SDTM, ADaM, and TLF deliverables using SAS. You will manage project timelines, ensure CDISC and regulatory compliance, and mentor junior programmers while working with international pharmaceutical and biotech clients.
About the Role
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.