Senior Statistical Programmer - CDISC SDTM/ADaM Lead

Katalyst CRO; Boulder (CO); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO in Boulder, Colorado, is seeking a Senior Statistical Programmer to act as the lead programmer and drive statistical programming activities for analysis datasets, listings, tables, and graphs supporting regulatory submissions.

The role entails collaboration with cross-functional teams to ensure data integrity for regulatory filings and internal reporting, with a focus on high-quality SAS programming and automation through macros and tools.

Qualifications

• Bachelor's degree in Biostatistics, Mathematics, Statistics, Computer Science, or related field.
• Minimum 6 years' experience in bio-pharma statistical programming.
• Advanced SAS programming skills in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with mastery of SAS/STAT procedures.
• Strong expertise in CDISC including SDTM, ADaM, and CDASH.
• Experience in regulatory submissions (NDAs, DSURs).
• High attention to detail and quality in deliverables.
• Strong teamwork and ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Independently develop, validate, document and troubleshoot SAS programs for internal reports, regulatory submissions, and ad hoc analyses.
• Create and maintain analysis and submission datasets (ADaM, SDTM) in CDISC standards.
• Design, develop, validate, update, and document SAS programs to generate datasets, tables, listings, and graphs.
• Support submission activities including data packages and eCTD deliverables.
• Develop software tools, SAS macros, and utilities to automate programming activities.

Skills

SAS programming

CDISC (SDTM/ADaM/CDASH)

SAS Macro

SAS/SQL

Education

Bachelor's degree in Biostatistics/Statistics/Math/CS or related field

Tools

SAS/Base

SAS/Macro

SAS/STAT

SAS/Graph

Job description

Katalyst CRO in Boulder, Colorado, is seeking a Senior Statistical Programmer to act as the lead programmer and drive statistical programming activities for analysis datasets, listings, tables, and graphs supporting regulatory submissions.

The role entails collaboration with cross-functional teams to ensure data integrity for regulatory filings and internal reporting, with a focus on high-quality SAS programming and automation through macros and tools.