The Statistical Programmer is an integral project team member in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data under the direction and oversight of a Senior Statistical Analyst. The Statistical Programmer interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.)

Responsibilities

• The Statistical Programmer will:
  - Create documentation for regulatory filings including reviewers guides and data definition documents.
  - Participate in the development of standard SAS Macros.
• The  Programmer will:
  - Consolidate heterogeneous data sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready data sets within a defined quality control process supporting a particular study.
  - Perform exploratory data analyses and visualizations in interaction with the clinical pharmacologist or pharmacometrician.
  - Produce dynamic and static data visualizations to communicate quantitative analyses.
• - Develop SAS programs for the creation of ADaM data sets following CDISC standards
• - Develop SAS programs for the creation of Tables, Listings and Figures.
  - Validation of ADaM data sets.
  - Validation of Tables, Listings and Figures.
  - Create specifications for the structure of ADaM data sets for individual studies.