**This is a hybrid position (3days a week on-site/2days remote). Candidates must be local and work hybrid out of Lake County, IL; San Francisco, CA; Irvine, CA; Florham Park, NJ 

The Statistical Analyst is an integral role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data without supervision for routine activities and with supervision for more complex activities. The Statistical Analyst interfaces with Statistics, Clinical Data Strategy & Operations and Development Operations.

Responsibilities:

• Leads the statistical programming activities for routine studies.
• Create documentation for regulatory filings including reviewers guides and data definition documents
• Participate in the development of standard SAS Macros, as well as, presenting information on existing Macros
• Pharmacometrics Only:
  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.
• Statistics Only:
  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 and integrated data