Senior Statistical Programmer

Atlas Search; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Atlas Search is seeking a Senior Statistical Programmer to independently lead programming activities for assigned clinical studies while hands-on in programming, validation, and oversight of datasets, tables, listings, figures, and regulatory deliverables.

You will develop/validate SDTM and ADaM datasets using SAS and R, review vendor deliverables, ensure CDISC compliance, and collaborate with Biostatistics, Data Management, and Clinical Operations to meet study timelines and regulatory

Qualifications

• Lead study-level programming activities and timelines.
• Develop, program, and validate SDTM and ADaM datasets, tables, listings, and figures using SAS and, where appropriate, R.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and cross-functional teams to clarify requirements and resolve issues.
• Review programs, datasets, outputs, and regulatory submissions for accuracy, traceability, and CDISC compliance.

Responsibilities

• Lead study-level programming activities, including planning and timeline management.
• Develop, validate SDTM/ADaM datasets and related outputs using SAS and R.
• Coordinate with cross-functional teams to resolve data and specification issues.
• Oversee vendor deliverables and support regulatory submissions.

Skills

Statistical programming

SDTM/ADaM

Vendor oversight

Cross-functional collaboration

Education

Bachelor’s degree in Statistics or related field

Tools

SAS

R

Job description

The Senior Statistical Programmer will independently lead programming activities for assigned clinical studies while maintaining hands-on involvement in programming, validation, and technical oversight. This role combines study-level ownership, strong knowledge of clinical study data, direct programming expertise, and oversight of internal and vendor-produced datasets, tables, listings, figures, and regulatory submission deliverables.

Responsibilities:

• Lead study-level statistical programming activities, including planning, prioritization, timeline management, risk identification, and status reporting.
• Develop, program, and validate SDTM and ADaM datasets, tables, listings, and figures using SAS and, where appropriate, R.
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and other cross-functional teams to clarify requirements and resolve data, programming, and specification issues.
• Review internally and externally developed programs, datasets, outputs, and regulatory submission deliverables to ensure accuracy, traceability, consistency, and compliance with CDISC standards and regulatory expectations.
• Provide oversight and technical review of vendor deliverables, including specifications, datasets, tables, listings, figures (TFLs), define.xml, annotated CRFs, reviewer guides, transport files, and validation documentation.
• Support clinical study publications, regulatory submissions, health authority requests, and inspection-readiness activities.
• Monitor programming deliverables, dependencies, timelines, and risks, escalating significant issues and developing solutions as needed.
• Partner with cross-functional stakeholders and external vendors to ensure programming activities remain aligned with study requirements and project timelines.

Qualifications:

• Bachelor’s degree in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or a related quantitative discipline.
• Minimum of 8+ years statistical programming experience in Biotech, Pharma, or CRO industry.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Experience overseeing vendor deliverables and supporting regulatory submissions.