Clinical Sas Programmer

• 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.
• Ability to work on interdisciplinary teams, including good organizational, interpersonal.