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SENIOR STATISTICAL PROGRAMMERS

Spark Life Solutions, Inc.
San Francisco, CA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/14/2025

Roles & Responsibilities :

  • Perform data manipulation, analysis and reporting of clinical trial data
  • Program and generate tables, listings, and graphs (TLGs)
  • Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.
  • Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
  • Participate in study team meetings and address issues that may affect statistical programming.
  • Validate and document SAS programs and output
  • Create SDTM and ADaM Datasets and related documentation
  • Fulfill ad-hoc programming requests
  • Other duties as needed

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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