Lead Statistical Programmer for SDTM/ADaM Submissions

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

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.