Lead Clinical SAS Programmer for Regulatory Submissions

Katalyst CRO; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Philadelphia, PA is seeking a Clinical SAS Programmer to join our team and represent the programming function in multi-disciplinary meetings. You will contribute to programming plans at study and project levels and provide input on key study documents produced by other functions.

The role emphasizes developing CDISC-compliant datasets, creating displays for regulatory submissions, and supporting statisticians with analytics. Remote work is not indicated.

Qualifications

• Minimum years of experience in developing software for clinical trials using the SAS system.
• Skilled in programming with SAS. Knowledge of additional programming languages a plus.
• Good knowledge of statistics and drug development process.
• Experience as a lead programmer for NDAs/BLAs.
• Experience overseeing the work of internal contractors and external vendors (CROs).

Responsibilities

• Developing CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
• Creating or reviewing software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
• Assisting statisticians by suggesting algorithms to address client analysis requests.
• Developing software validation procedures and test plans

Skills

SAS programming

Clinical trials

Team leadership

Vendor management

Job description

Katalyst CRO in Philadelphia, PA is seeking a Clinical SAS Programmer to join our team and represent the programming function in multi-disciplinary meetings. You will contribute to programming plans at study and project levels and provide input on key study documents produced by other functions.

The role emphasizes developing CDISC-compliant datasets, creating displays for regulatory submissions, and supporting statisticians with analytics. Remote work is not indicated.