Senior Statistical Programmer - SDTM/ADaM Expert

Katalyst CRO; Los Angeles (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a Sr. Statistical Programmer in Los Angeles to support biostatistics with analysis datasets, tables, listings, and figures for regulatory submissions and publications.

The role emphasizes SDTM/ADaM standardization, development of templates/macros, and collaboration with cross-functional teams to ensure timely, high-quality deliverables in a regulated environment.

Qualifications

• 5+ years of statistical programming experience in pharma/biotech.
• Attention to regulatory processes and GLP/GxP expectations.
• Working knowledge of CDISC SDTM/ADaM standards.

Responsibilities

• Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures.
• Implement and maintain standardized programming templates, macros, and tools.
• Collaborate with statisticians, data managers, and vendors to ensure timely deliverables.
• Review SAPs with biostatisticians and anticipate programming complexities.
• QC and validate datasets and outputs per SOPs and best practices.
• Document activities for reproducibility and regulatory compliance.
• Use version control and structured documentation for audit readiness.
• Contribute to posters, presentations, or ad hoc analyses.

Skills

SAS programming

CDISC SDTM/ADaM

GxP compliance

Regulatory submissions

Education

Bachelor's degree or higher

Tools

SAS

Job description

Katalyst CRO is seeking a Sr. Statistical Programmer in Los Angeles to support biostatistics with analysis datasets, tables, listings, and figures for regulatory submissions and publications.

The role emphasizes SDTM/ADaM standardization, development of templates/macros, and collaboration with cross-functional teams to ensure timely, high-quality deliverables in a regulated environment.