Katalyst CRO
Overview
Statistical Programmer at Katalyst CRO. This role involves developing SAS programs and statistical output for management and reporting of clinical trial data, ensuring quality of outputs, contributing to regulatory submissions, and supporting data review and interpretation of trial results. Responsibilities
Develop SAS programs and statistical output for the management and reporting of clinical trial data. Guarantee quality of statistical output produced by external providers; develop tools to support data review, data visualization, and collaboration on interpretation and communication of trial results. Contribute to regulatory submissions by converting data according to regulatory requirements, preparing integrated analyses and related documentation. Perform post-hoc analyses for exploratory purposes or to support regulatory requests; prepare analyses for paper publications. Support the development of standard operating procedures. Convert data to CDISC SDTM according to project specifications. Develop SAS programs to generate analysis datasets (CDISC compliant). Produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or review analysis datasets documentation prepared by providers. Develop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review before database lock. Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports. Write, document, and perform quality control reviews of SAS programs. Perform ad hoc analyses for various statisticians’ requirements. Support statisticians in the preparation, review, and quality control of statistical packages for FDA submissions. Perform QC of programming material prepared by external providers to ensure output is correct and aligned with international requirements and internal SOPs/Standards. Requirements
Bachelor's degree or higher in a scientific discipline (Statistics, Mathematics, Computer Science, or related field). Good experience in SAS; proficient in Macro Facility. Extensive involvement in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries, and Graphs according to SOPs. Knowledge of CDISC standards (SDTM, ADaM, ODM) and Define.xml. General knowledge of statistical methods. Excellent analytical, problem-solving, communication, and interpersonal skills; effective verbal and written communication. Strong commitment to quality; ability to work in a team-based environment. Job Details
Seniority level: Associate Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr
Statistical Programmer at Katalyst CRO. This role involves developing SAS programs and statistical output for management and reporting of clinical trial data, ensuring quality of outputs, contributing to regulatory submissions, and supporting data review and interpretation of trial results. Responsibilities
Develop SAS programs and statistical output for the management and reporting of clinical trial data. Guarantee quality of statistical output produced by external providers; develop tools to support data review, data visualization, and collaboration on interpretation and communication of trial results. Contribute to regulatory submissions by converting data according to regulatory requirements, preparing integrated analyses and related documentation. Perform post-hoc analyses for exploratory purposes or to support regulatory requests; prepare analyses for paper publications. Support the development of standard operating procedures. Convert data to CDISC SDTM according to project specifications. Develop SAS programs to generate analysis datasets (CDISC compliant). Produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or review analysis datasets documentation prepared by providers. Develop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review before database lock. Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports. Write, document, and perform quality control reviews of SAS programs. Perform ad hoc analyses for various statisticians’ requirements. Support statisticians in the preparation, review, and quality control of statistical packages for FDA submissions. Perform QC of programming material prepared by external providers to ensure output is correct and aligned with international requirements and internal SOPs/Standards. Requirements
Bachelor's degree or higher in a scientific discipline (Statistics, Mathematics, Computer Science, or related field). Good experience in SAS; proficient in Macro Facility. Extensive involvement in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries, and Graphs according to SOPs. Knowledge of CDISC standards (SDTM, ADaM, ODM) and Define.xml. General knowledge of statistical methods. Excellent analytical, problem-solving, communication, and interpersonal skills; effective verbal and written communication. Strong commitment to quality; ability to work in a team-based environment. Job Details
Seniority level: Associate Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr