Clinical SAS Programmer

4 weeks ago

Danvers, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Produce and validate biostatistics deliverables including CDISC datasets (SDTM/ADaM), Tables, Listings, and Figures (TLFs), and patient profiles using SAS.
  • Ensure high quality and accurate work in the programming process and consistency with the Statistical Analysis Plan and other specification documents.
  • Develop and review dataset and/or output specifications.
  • Develop and maintain standard programming tools (macros, etc.) to be used across all studies.
  • Develop and maintain tracking systems, folder systems and archival of deliveries. (Sr Stat Prog Only) .
  • Support internal and external requests for input into relevant documentation including the Statistical Analysis Plan, manuscripts, presentations, and ad hoc reports.
  • Represent the Biostatistics group in internal and external team meetings.
  • Communicate to management on project status and resource issues. (Sr Stat Prog Only)
  • Participates in the development of Standard Operating Procedures (SOPs) and guidelines. (Sr Stat Prog Only for development) .
  • Ensures compliance with Standard Operating Procedures (SOPs) and guidelines.
  • Other duties as assigned.
Requirements:
  • B.S with at least 1+ years or M.S. with at least 5+ years as a statistical programmer in the pharmaceutical industry.
  • Experience leading SAS programming projects in the pharmaceutical industry.
  • Some experience with R is beneficial, but not required.
  • Experience with CDISC Foundational Standards, especially SDTM and ADaM
  • Experience creating Define.XML, Reviewer's Guides, and data submission packages.
  • Experience with Pinnacle 21 validation.
  • bility to work on interdisciplinary teams, including good organizational, interpersonal.