Katalyst Healthcares and Life Sciences
Clinical SAS Programmer
Katalyst Healthcares and Life Sciences, Los Angeles, California, United States, 90079
Responsibilities:
Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol. Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets. Review and QC submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate. Provide CDISC training and serve as subject matter support to project staff. Maintain and coordinate CDISC standards efforts, ensure maximum reuse of applied standards, involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance. Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation. Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good understanding of the statistical programming domain and related processes. Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentation. Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity. Requirements:
Bachelor's or master's degree in computer science, Management Information Systems, or a related field. Minimum of 5 years of experience in using SAS to process and analyze large datasets. Experience in conducting data quality reviews including clinical data, tables, graphs, and reports. Experience in developing technical documentation. SAS Certified Base Programmer certification required. Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards. Good organizational and communication skills, the ability to work in a collaborative environment, and a desire to improve skills are essential. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes' SDTM Implementation Guide, project standards, and the study protocol. Create DEFINE specifications for mapping of SDTM and ADaM compliant datasets. Review and QC submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate. Provide CDISC training and serve as subject matter support to project staff. Maintain and coordinate CDISC standards efforts, ensure maximum reuse of applied standards, involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance. Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation. Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations. Good understanding of the statistical programming domain and related processes. Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentation. Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity. Requirements:
Bachelor's or master's degree in computer science, Management Information Systems, or a related field. Minimum of 5 years of experience in using SAS to process and analyze large datasets. Experience in conducting data quality reviews including clinical data, tables, graphs, and reports. Experience in developing technical documentation. SAS Certified Base Programmer certification required. Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards. Good organizational and communication skills, the ability to work in a collaborative environment, and a desire to improve skills are essential. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.