Katalyst CRO
SAS Programmer – Katalyst CRO
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SAS Programmer
role at
Katalyst CRO .
Responsibilities
Develop and validate programs that create datasets conforming to CDISC standards.
Drive the creation of Tables, Listings, and Figures for analysis.
Lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.
Mentor junior programmers and represent Statistical Programming in meetings with internal and external clients.
Integrate statistical concepts with SAS Programming efficiently and effectively.
Support development of technical programming specifications for SDTM, ADS, or ADaM standards.
Independently develop and/or validate programs that generate SDTM and analysis datasets based on company or ADaM specifications.
Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.
Manage external vendors and contract programmers.
Provide project progress updates of programming activities.
Review, maintain, and approve protocol-specific documents as necessary.
Offer guidance and mentoring to peers, junior-level programmers, and contract staff.
Support project leadership by ensuring department standards are implemented in all studies.
Contribute ideas and thoughts towards the optimization of standard operating procedures.
Lead team meetings when appropriate.
Resolve problems independently and collaboratively.
Requirements
Statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
Clearly communicate processes and standards with management and team members.
Competence in using SAS/Base, SAS/Macro, SAS/STAT.
Knowledge of SAS/Graph and SAS/SQL.
Knowledge and implementation of SDTM and ADaM principles.
Experience with Relational Databases.
Good Clinical Practice principles.
Good Programming Practice principles.
21CFR Part 11 Standards principles.
Integrated Summary Safety/Efficacy Analyses.
Safety data and Coding Dictionaries (MedDRA and WHO-DD).
ICH eCTD format.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Information Technology
Industries Biotechnology Research and IT Services and IT Consulting
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SAS Programmer
role at
Katalyst CRO .
Responsibilities
Develop and validate programs that create datasets conforming to CDISC standards.
Drive the creation of Tables, Listings, and Figures for analysis.
Lead programming projects, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.
Mentor junior programmers and represent Statistical Programming in meetings with internal and external clients.
Integrate statistical concepts with SAS Programming efficiently and effectively.
Support development of technical programming specifications for SDTM, ADS, or ADaM standards.
Independently develop and/or validate programs that generate SDTM and analysis datasets based on company or ADaM specifications.
Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.
Manage external vendors and contract programmers.
Provide project progress updates of programming activities.
Review, maintain, and approve protocol-specific documents as necessary.
Offer guidance and mentoring to peers, junior-level programmers, and contract staff.
Support project leadership by ensuring department standards are implemented in all studies.
Contribute ideas and thoughts towards the optimization of standard operating procedures.
Lead team meetings when appropriate.
Resolve problems independently and collaboratively.
Requirements
Statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
Clearly communicate processes and standards with management and team members.
Competence in using SAS/Base, SAS/Macro, SAS/STAT.
Knowledge of SAS/Graph and SAS/SQL.
Knowledge and implementation of SDTM and ADaM principles.
Experience with Relational Databases.
Good Clinical Practice principles.
Good Programming Practice principles.
21CFR Part 11 Standards principles.
Integrated Summary Safety/Efficacy Analyses.
Safety data and Coding Dictionaries (MedDRA and WHO-DD).
ICH eCTD format.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Information Technology
Industries Biotechnology Research and IT Services and IT Consulting
#J-18808-Ljbffr