Spark Life Solutions, Inc.
SENIOR STATISTICAL PROGRAMMERS
Spark Life Solutions, Inc., San Francisco, California, United States, 94199
Roles & Responsibilities:Perform data manipulation, analysis and reporting of clinical trial dataProgram 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 outputCreate SDTM and ADaM Datasets and related documentationFulfill ad-hoc programming requestsOther duties as neededEducation & Experience:
15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companiesStrong submissions experience (BLA, NDA/sNDA and EMA) and end to end programming experienceKnowledge 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 projectExperience working in the Cardiovascular or Neuromuscular areas is a plus
15+ years of statistical programming experience in the pharmaceutical/biotech industries, strong tenure with Sponsor companiesStrong submissions experience (BLA, NDA/sNDA and EMA) and end to end programming experienceKnowledge 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 projectExperience working in the Cardiovascular or Neuromuscular areas is a plus