Senior Statistical Programmer

4 days ago


San Francisco, California, United States Spark Life Solutions, Inc. Full time
Roles & Responsibilities:
At Spark Life Solutions, Inc., we are seeking a skilled Senior Statistical Programmer to join our team. The ideal candidate will have a strong background in statistical programming and experience working with clinical trial data. Key responsibilities include performing data manipulation, analysis, and reporting, as well as generating tables, listings, and graphs. Additionally, the successful candidate will participate in the review of statistical analysis plans, develop specifications for SDTM and ADaM data sets, and validate and document SAS programs and output.

Education & Experience:
15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companies. Strong submissions experience (BLA, NDA/sNDA and EMA) and end-to-end programming experience. Knowledge and experience working with CDISC Standards (MUST have expertise in both SDTM/ADaM, developing specifications for both). Demonstrated ability performing all levels of programming activities for a clinical project. Experience working in the Cardiovascular or Neuromuscular areas is a plus.

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