• Contract
  • Remote

SimulStat

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Remote, 12-month contract with potential to extend

The Senior Statistical Programmer will provide statistical programming support for multiple clinical studies, including ad hoc requests, safety reports, manuscripts, posters, presentations with high efficiency. Primary focus will be to help with the ISS/ISE or work on CDSIC review for 2 registrational phase 3 studies

Responsibilities:

  • Effectively develop SAS programs for study related ad hoc requests, manuscripts, posters, and presentations
  • Create or review and approve CDISC compliant SDTM and ADaM datasets and validate datasets/analysis files, tables, listings, and figures (TLFs) and corresponding documentation for electronic submission to regulatory agencies

Qualifications:

  • Bachelor’s degree and 5+ years of experience in leading and supporting statistical programming activities in clinical research for all phases of clinical trials, supporting global trials. Experience in Immunology a plus.
  • Experience with all SAS language including Macro, SQL, SAS/GRAPH, knowledge of advanced SAS procedures including LIFETEST, PHREG, MIXED, GLM,
  • Experience with the CDISC, SDTM, ADaM models and transforming raw data into these standards
  • Strong ADaM dataset pooling for ISS/ISE
  • Experience working with all types of safety data and coding dictionaries (MedDRA and WHODDE)
  • Knowledge of FDA and ICH regulations
  • Solid verbal and written communication skills

 

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