Statistical Programmer II

Katalyst CRO


Date: 1 week ago
City: Elk Grove Village, IL
Contract type: Full time
Responsibilities

  • Develop statistical programs in SAS to generate the clinical datasets, tables, listings and figures.
  • Perform validation and QC of the programs, datasets and statistical reports per study requirements.
  • Develop and review CDISC SDTM and ADaM mapping specifications.
  • Responsible for study closeout and providing submission-ready statistical programming deliverables to the client.
  • Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC validator and documenting issues.
  • Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide.
  • Ensure review of study documents such as Protocol, CRF, and SAP.
  • Communicates effectively within a project team to complete assigned tasks on time and within budget.
  • Effectively implement and promote use of established standards, SOP and best practices.
  • Provide training and mentoring to junior programmers in the team.

Requirements:

  • Master's degree or equivalent and relevant formal academic / vocational qualification.
  • 5yrs SAS programming experience.
  • 1-2yrs CDISC implementation experience.
  • Proficient in SAS and Macros and have developed macros to automate functionality.
  • Participated as production or QC programmer at a product and/or study level.
  • Experience working in Oncology, CNS or Rare Disease therapeutic areas.
  • Good organizational, interpersonal, leadership and communication skills.
  • bility to independently manage multiple tasks and projects.

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