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Clinical SAS Programmer

  • Provide statistical programming support per requests from Biostatisticians and other functional areas such as medical/clinical or medical writing
  • Develop, maintain, and validate SAS program/macros for study specific analysis or at the standard level
  • Generate TFLs per table shells or ad hoc requests; perform validation to TFLs that generated by other programmers per table shells or ad hoc requests
  • Attend internal or cross-functional meetings with inputs from Statistical Programming group
  • Oversee and manage programming activities which may be conducted by external vendors
  • Work with external vendors in order to develop or monitor the content and structure of SAS and related Software installations
  • Develop and maintain SOPs, Lifecycle Data Standards and other related technical documents, provide input and feedback
  • Provide input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents and determining and researching SAS software upgrades and related system maintenance issues
  • Write and Executing systems and macro testing, and deliver training
  • Generate SDTM/ADaM datasets and associated specs files; perform validation to SDTM/ADaM datasets that generated by other programmers per specs files
  • Experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment
  • Experience in a pharmaceutical/CRO programming environment or demonstrated understanding of SAS programming activities in a clinical pharmaceutical/CRO environment
  • Validation and Systems Development Life Cycle
  • Experience using SAS-Base, MACRO, STAT, GRAPH, MS Office and R.
  • Understanding of regulatory guidelines
  • Hands-on experience with industry tools including biostatistics platforms, ETL, standard reporting and visualization tools