Senior Statistical Programmer

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

Job summary

Atlas Search in the United States seeks a Senior Statistical Programmer to lead programming activities for clinical studies, with hands-on involvement in programming, validation, and regulatory deliverables.

You will develop and validate SDTM/ADaM datasets, tables, listings, and figures using SAS and R, collaborate across Biostatistics, Data Management, and Clinical Operations, and oversee vendor submissions and regulatory readiness.

Qualifications

• Bachelor's degree in a related quantitative discipline.
• 8+ years statistical programming experience in Biotech, Pharma, or CRO.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Experience overseeing vendor deliverables and supporting regulatory submissions.

Responsibilities

• Lead study-level programming activities with planning and timelines.
• Develop, program, and validate SDTM/ADaM datasets, tables, listings, figures using SAS and R.
• Collaborate with cross-functional teams to clarify requirements and resolve issues.
• Review programs, datasets, outputs, and submission deliverables for CDISC compliance.
• Provide oversight of vendor deliverables including define.xml, TFLs, and validation docs.
• Support publications, regulatory submissions, health authority requests, and inspections readiness.
• Monitor deliverables, timelines, risks, and escalate issues.
• Coordinate with stakeholders and vendors to align with study requirements.

Skills

Leadership

Cross-functional collaboration

Regulatory submissions support

Project management

Education

Bachelor's degree in Statistics/Biostatistics/CS/Math/Life Sciences

Tools

SAS

R

CDISC SDTM/ADaM

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.