Senior Statistical Programmer

Location: Aventura, FL, United States
Date Posted: 10-04-2018

Primary Responsibilities:
  • Manage or lead assignments and programming personnel on single or multiple clinical trial projects.
  • Development of programming specifications for data validation, transformation and analysis including both descriptive and inferential statistics
  • Development of data transformation and analysis programs, primarily using SAS® to create and or validate: 1) SDTM domains and/or ADaM datasets, 2) Tables, listings and figures
  • Annotate case report forms
  • Prepare Define.XMLs
  • Compose Data Reviewers Guides for both SDTM and ADaM
  • Develop and maintain standard programs, macros, templates, and libraries for use in clinical studies
  • Leads the creation, review and criticism of project documents (e.g. SAP, CSP, CSR)
Secondary Responsibilities:
  • Develop and run data analytics programs to assess data quality and consistency across sites in support of clinical monitoring, project management and safety
  • Lead a project programming team
  • Act as study point of contact for statisticians and data management personnel
  • Lead the completion of final study reports and other publication activities
  • Create and update data sciences SOPs, guidance, training classes and materials.
Qualifications and Experience Required:
  • Bachelor Degree in Mathematics, Information Technology or related field
  • 5 years relevant experience acceptable to the Company. Advanced Degree preferred.
  • 5‐8 years Programming Experience, preferably in a business or clinical data context
  • Knowledge of FDA, ICH and GCP guidelines
  • Excellent organizational skills.
  • Strong verbal and written communications skills.
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