Clinical SAS Programmer

2 weeks ago

Los Angeles, CA, United States Katalyst Healthcares and Life Sciences Full time
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.
  • ssists 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.

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