Katalyst CRO
Overview
Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs. The programmer develops and validates SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) that support clinical trial reporting, regulatory submissions, and publications. They implement and maintain standardized programming templates, macros, and tools to ensure consistency, efficiency, and compliance across clinical studies. They contribute to the creation and review of programming specifications for SDTM and ADaM-like datasets based on CDISC standards and internal guidelines, assist in programming support for data cleaning, interim analyses, medical review, and final study reports, and collaborate with statisticians, data managers, clinical team members, and external vendors to ensure timely and high-quality deliverables. The role involves reviewing Statistical Analysis Plans (SAP) with biostatisticians to anticipate potential programming complexities, performing quality control (QC) and validation of datasets and outputs in line with SOPs and programming best practices, and integrating data across multiple studies for pooled analyses or submission packages to support regulatory filings or internal strategy. Documentation and version control are used to support audit readiness and reproducibility in a validated programming environment. The Sr. Statistical Programmer may contribute to posters, presentations, or ad hoc analyses, including visual data summaries using SAS graphics or other data visualization tools. Other duties as required.
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Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs. The programmer develops and validates SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) that support clinical trial reporting, regulatory submissions, and publications. They implement and maintain standardized programming templates, macros, and tools to ensure consistency, efficiency, and compliance across clinical studies. They contribute to the creation and review of programming specifications for SDTM and ADaM-like datasets based on CDISC standards and internal guidelines, assist in programming support for data cleaning, interim analyses, medical review, and final study reports, and collaborate with statisticians, data managers, clinical team members, and external vendors to ensure timely and high-quality deliverables. The role involves reviewing Statistical Analysis Plans (SAP) with biostatisticians to anticipate potential programming complexities, performing quality control (QC) and validation of datasets and outputs in line with SOPs and programming best practices, and integrating data across multiple studies for pooled analyses or submission packages to support regulatory filings or internal strategy. Documentation and version control are used to support audit readiness and reproducibility in a validated programming environment. The Sr. Statistical Programmer may contribute to posters, presentations, or ad hoc analyses, including visual data summaries using SAS graphics or other data visualization tools. Other duties as required.
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