Statistical Programmer II

4 days ago

Aliso Viejo, California, United States Glaukos Full time $80,000 - $120,000 per year

What You'll Do:

The Statistical Programmer II will work onsite in our corporate headquarters in Aliso Viejo, CA . The Statistical Programmer II generates datasets, tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications. This position requires a basic understanding and ability to provide datasets using current industry standards including Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

  • Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with Statisticians and other clinical team members to ensure programming requirements are understood. i.e . Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production. i.e . Following the SDTM Implementation Guide and written specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets.
  • Generate tables, figures, and listings, (TFLs) in accordance with the SAP and TFL shells to support analyses using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology. Assist in validating SAS programs, macros, datasets, and TFL output generated by other Programmers. Other duties as assigned

How You'll Get There:

  • 3+ years of experience required with BA/BS Degree, 2+ years of experience with Master's Degree
  • High proficiency in SAS programming
  • Experience working with CDISC SDTM and/or ADaM compliant data sets
  • Knowledge of statistics and the drug development process
  • Knowledge of FDA/ICH guidelines and industry/technology standard practices
  • Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
  • Solid verbal and written communication skills
  • Bachelor's /Master's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required;
  • Master's degree is preferred.
  • Great compensation and benefits
    This is not a remote role and we are willing to assist with relocation
GKOSUS

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