Clinical Data Analyst

4 weeks ago


Danvers, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Clinical SAS Programmer

We are seeking a highly skilled Clinical SAS Programmer to join our team at Katalyst Healthcares and Life Sciences. As a key member of our Biostatistics group, you will be responsible for producing and validating biostatistics deliverables, including CDISC datasets, tables, listings, and figures.

Responsibilities:
  • Develop and validate biostatistics deliverables, including CDISC datasets, tables, listings, and figures 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.
  • 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.
  • Participate in the development of Standard Operating Procedures (SOPs) and guidelines.
  • Ensure compliance with Standard Operating Procedures (SOPs) and guidelines.
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.
  • Ability to work on interdisciplinary teams, including good organizational, interpersonal, and communication skills.


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