Lead Clinical Statistical Programmer for Regulatory Submissions

Atlas Search; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Atlas Search seeks a Senior Statistical Programmer to independently lead programming activities for assigned clinical studies, while staying hands-on with programming, validation, and oversight of datasets, tables, listings, figures, and regulatory submissions.

Responsibilities include planning, prioritization, and risk management; developing SDTM/ADaM datasets in SAS and R; collaborating with cross-functional teams to resolve data issues; reviewing vendor deliverables and supporting

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.

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 with Biostatistics, Data Management, Clinical Operations, and cross-functional teams to clarify requirements and resolve data and programming issues.
• Review internal and external programs, datasets, outputs, and regulatory submission deliverables for accuracy, traceability, and compliance with CDISC standards.
• Provide oversight and technical review of vendor deliverables, including datasets, tables, listings, figures (TFLs), define.xml, and validation documentation.
• Support clinical study publications, regulatory submissions, health authority requests, and inspection-readiness activities.
• Monitor programming deliverables, dependencies, timelines, and risks, escalating issues and developing solutions as needed.
• Partner with cross-functional stakeholders and external vendors to ensure programming activities align with study requirements and project timelines.

Skills

SAS

R

CDISC standards

SDTM

ADaM

Vendor oversight

Data programming

Collaboration

Education

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

Job description

Atlas Search seeks a Senior Statistical Programmer to independently lead programming activities for assigned clinical studies, while staying hands-on with programming, validation, and oversight of datasets, tables, listings, figures, and regulatory submissions.

Responsibilities include planning, prioritization, and risk management; developing SDTM/ADaM datasets in SAS and R; collaborating with cross-functional teams to resolve data issues; reviewing vendor deliverables and supporting