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Clinical SAS Programmer

3 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.