Statistical Programmer


Geneva, Switzerland

Summary of Job Responsibilities:

Working under the direction of the Biostatistician or Senior Statistical Programmer, the Statistical Programmer:

  • conducts programming activities for a trial, early phase project, indication, or publication activities;
  • дevelops and supports statistical programming computer systems that are used in the production of statistical analysis plan (SAP)-planned tables, data listings, and graphs, integrated summaries of safety and efficacy, ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, programs, programming table of contents, and patient profiles;
  • creates systems that assist the bio statistical programming staff and bio statistical staff to create tables, data listings, graphs, and analysis for final reports, abstracts, posters, manuscripts, and other clinical publications;
  • develops systems to support electronic regulatory submissions;
  • provides systems and support for clinical data management staff, clinical programmers, quality control (QC) staff, and biostatisticians;
  • produces and supports systems that extract data from the clinical database; and building analysis databases composed of SAS datasets. The Statistical Programmer must:
    • follow established standardized design and programming procedures;
    • assist in establishing standardized programming procedures and work instructions;
    • develop, enhance, evaluate, and validate standardized macros and utility programs;
    • ensure that regulatory requirements are met through validation/compliance activities;
    • develop and maintain clinical processing work flow systems.

Qualifications and Experience:

  • BS or MS degree in Computer Science, Statistics, or related health science field with a minimum of 1 year of SAS programming experience with clinical trial data;
  • General knowledge of regulatory requirements and drug development process;
  • Excellent organizational skills and good verbal and written communication skills;
  • Ability to work independently is required.

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