Clinical SAS Programmer

3 weeks ago

Chula Vista, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
  • Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Review output across SAS programs to ensure consistency.
  • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Participate in the development and/or maintenance of departmental procedures and standards.
  • Review CRFs, edit check specifications, and table mock-ups.
  • Work collaboratively with cross functional groups, study team, and vendors.
  • May assist in creation of table, figure, or listing mockups under supervision of statisticians.
Requirements:
  • You should have a bachelor's degree in Statistics, Mathematics, or a related field.
  • Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
  • Demonstrate extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • NDA submission experience is a plus.
  • We will consider remote candidates; however, San Diego-based candidates are preferred.