Katalyst Healthcares and Life Sciences
Clinical SAS Programmer
Katalyst Healthcares and Life Sciences, Florham Park, New Jersey, us, 07932
Responsibilities:
Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at the project level.Generate and/or review SDTM mapping specifications, annotated CRFs, ADaM specifications, Define.XML documents, and reviewer's guides per CDISC and FDA specifications and guidelines using standard tools and templates.Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.ccountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.Manage all aspects of Statistical Programming deliverables for multiple studies/projects.Support in the development and review of global standards, templates, processes, SOPs and Work Instructions.Partner with cross-functional groups on timelines, vendor selection and CRO oversight.Requirements:
BS or MS in Computer Science or Biostatistics.Minimum of 5 years of industry experience in Statistical Programming to include oversight of CRO deliverables.Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.Experience in the development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.Good knowledge of 21CFR11 and GCP.Good knowledge of Drug development process and BiostatisticsCurrent knowledge in technologies and tools related to Statistical programming or Biostatistics.
Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at the project level.Generate and/or review SDTM mapping specifications, annotated CRFs, ADaM specifications, Define.XML documents, and reviewer's guides per CDISC and FDA specifications and guidelines using standard tools and templates.Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.Create all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.ccountable for oversight of Statistical Programming deliverables on project level for inhouse and outsourced projects.Manage all aspects of Statistical Programming deliverables for multiple studies/projects.Support in the development and review of global standards, templates, processes, SOPs and Work Instructions.Partner with cross-functional groups on timelines, vendor selection and CRO oversight.Requirements:
BS or MS in Computer Science or Biostatistics.Minimum of 5 years of industry experience in Statistical Programming to include oversight of CRO deliverables.Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.Experience in the development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/Client.Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.Good knowledge of 21CFR11 and GCP.Good knowledge of Drug development process and BiostatisticsCurrent knowledge in technologies and tools related to Statistical programming or Biostatistics.