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  • Effectively develops SAS programs for clinical study reports, for regulatory submission, and for IB updates, DSUR, PSUR, interim analysis
  • Develops complex SAS programs and performs quality control checks for SAS code and outputs produced by CROs as required
  • Reviews SDTM ADaM mapping specs, validates SDTM, ADaM datasets and TFLs
  • Identifies problems and develops global tools that increase the efficiency and capacity
  • Responsible for maintaining/archiving medical database, SAS programs and results, and documentations
  • Participates technical meetings including internal and external representatives
  • Qualifications

  • Bachelor/Master's Degree/in Biostatistics, Mathematics, Statistics, Computer Science, Life Science (or equivalent degree)
  • 5-8 years of relevant pharmaceutical industry work experience, oncology experience is preferred
  • Experience writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials
  • Experience with creating all files, documents, and analyses necessary to support an electronic submissions in eCTD format, including ISS/ISE
  • Experience with SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
  • Experience with the CDISC SDTM and AdaM models and transforming raw data into these standards
  • Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry

  • Associated topics: biostatistics, data analyst, probability, statistics, c

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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