Clinical SAS Programmer

2 weeks ago


San Diego, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Serves as the primary project team representative, delegating work as appropriate
  • Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains
  • Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data
  • Reviews output across programs to ensure consistency
  • Reviews maintains and approves study documents per standard procedures
  • Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
  • Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures
  • Provides technical expertise to the development of programming standards and procedures, technical expertise in the areas of analysis and reporting
  • Participates in the development and/or maintenance of departmental procedures and standards
Requirements:
  • BS/BA degree in computer science, mathematics, statistics, or related discipline and 3+ years' experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, you must have at least three years of experience serving in a supervisory or lead capacity. Experience managing projects OR
  • Master's degree in computer science, mathematics, statistics, or related discipline and 4+ years of similar experience noted above OR
  • PhD in computer science, mathematics, statistics, or related discipline and 2+ years of similar experience noted above
  • Demonstrates strong knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
  • Strong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar
  • Strong knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains
  • Ability to work as part of a team; may train lower levels


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