Address
Form of work 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.
- Ability to work on interdisciplinary teams, including good organizational, interpersonal.
