Katalyst CRO
Statistical Programmer
Join Katalyst CRO as a Statistical Programmer to develop SAS programs and statistical output for clinical trial data management and reporting. You will guarantee quality of statistical output produced by external providers, support regulatory submissions, perform ad hoc analyses, and contribute to standard operating procedures. Responsibilities
Develop SAS programs for analysis datasets and statistical output (tables, listings, figures) as per the statistical analysis plan. Convert data to CDISC SDTM and produce datasets documentation (define.xml) per FDA and CDISC requirements. Ensure quality control of SAS programs, including review of external provider material and internal SOP compliance. Support statisticians in preparation and review of statistical packages for FDA submissions. Perform post‑hoc exploratory analyses and support regulatory requests and publication preparation. Contribute to the development of standard operating procedures. Requirements
Bachelor’s degree or higher in Statistics, Mathematics, Computer Science, or a related scientific discipline. Strong experience in SAS, particularly with Macro Facility. Extensive experience in clinical data analysis and preparation of SAS data sets, reports, tables, listings, summaries, and graphs according to SOPs. Knowledge of CDISC standards including SDTM, ADaM, ODM, and Define.xml. General knowledge of statistical methods and data quality evaluation. Excellent analytical, problem‑solving, communication, and interpersonal skills. Strong commitment to quality and ability to work in a team‑based environment.
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Join Katalyst CRO as a Statistical Programmer to develop SAS programs and statistical output for clinical trial data management and reporting. You will guarantee quality of statistical output produced by external providers, support regulatory submissions, perform ad hoc analyses, and contribute to standard operating procedures. Responsibilities
Develop SAS programs for analysis datasets and statistical output (tables, listings, figures) as per the statistical analysis plan. Convert data to CDISC SDTM and produce datasets documentation (define.xml) per FDA and CDISC requirements. Ensure quality control of SAS programs, including review of external provider material and internal SOP compliance. Support statisticians in preparation and review of statistical packages for FDA submissions. Perform post‑hoc exploratory analyses and support regulatory requests and publication preparation. Contribute to the development of standard operating procedures. Requirements
Bachelor’s degree or higher in Statistics, Mathematics, Computer Science, or a related scientific discipline. Strong experience in SAS, particularly with Macro Facility. Extensive experience in clinical data analysis and preparation of SAS data sets, reports, tables, listings, summaries, and graphs according to SOPs. Knowledge of CDISC standards including SDTM, ADaM, ODM, and Define.xml. General knowledge of statistical methods and data quality evaluation. Excellent analytical, problem‑solving, communication, and interpersonal skills. Strong commitment to quality and ability to work in a team‑based environment.
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