Katalyst CRO
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Statistical Programmer II
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Katalyst CRO . 2 months ago Be among the first 25 applicants. Responsibilities: Develop statistical programs in SAS to generate clinical datasets, tables, listings, and figures. Perform validation and QC of programs, datasets, and statistical reports per study requirements. Develop and review CDISC SDTM and ADaM mapping specifications. Manage study closeout and deliver submission-ready statistical programming outputs to clients. Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC validator and documenting issues. Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide. Review study documents like Protocol, CRF, and SAP. Communicate effectively within project teams to complete tasks on time and within budget. Implement and promote use of established standards, SOPs, and best practices. Provide training and mentorship to junior programmers. Requirements: Master's degree or equivalent with relevant academic/vocational qualification. At least 5 years of SAS programming experience. 1-2 years of CDISC implementation experience. Proficiency in SAS and macros, with macro development experience. Experience as a production or QC programmer at product/study level. Experience in Oncology, CNS, or Rare Disease therapeutic areas. Strong organizational, interpersonal, leadership, and communication skills. Ability to manage multiple tasks independently. Additional Details: Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing
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Statistical Programmer II
role at
Katalyst CRO . 2 months ago Be among the first 25 applicants. Responsibilities: Develop statistical programs in SAS to generate clinical datasets, tables, listings, and figures. Perform validation and QC of programs, datasets, and statistical reports per study requirements. Develop and review CDISC SDTM and ADaM mapping specifications. Manage study closeout and deliver submission-ready statistical programming outputs to clients. Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC validator and documenting issues. Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide. Review study documents like Protocol, CRF, and SAP. Communicate effectively within project teams to complete tasks on time and within budget. Implement and promote use of established standards, SOPs, and best practices. Provide training and mentorship to junior programmers. Requirements: Master's degree or equivalent with relevant academic/vocational qualification. At least 5 years of SAS programming experience. 1-2 years of CDISC implementation experience. Proficiency in SAS and macros, with macro development experience. Experience as a production or QC programmer at product/study level. Experience in Oncology, CNS, or Rare Disease therapeutic areas. Strong organizational, interpersonal, leadership, and communication skills. Ability to manage multiple tasks independently. Additional Details: Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industry: Pharmaceutical Manufacturing
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