Statistical Programmer
About The Position
The Statistical Programmer is an integral project team member in the research and development of new pharmaceutical products. The role analyzes and reports clinical trial data under the direction and oversight of a Senior Statistical Analyst, and interfaces with stakeholders in Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing, and Development Operations. The Programmer consolidates clinical study, external, and real-world data sources into analysis-ready datasets within a defined quality-control process. The role performs exploratory data analyses and visualizations with clinical pharmacologists or pharmacometricians, develops dynamic and static visualizations, creates SAS programs and documentation for regulatory filings, and validates ADaM datasets and Tables, Listings, and Figures.
Requirements
- Master’s degree in Statistics, Computer Science, or a related field with 0 or more years of relevant experience, or a bachelor’s degree in Statistics, Computer Science, or a related field with 2 or more years of relevant experience.
- Demonstrated practical understanding of SAS programming or NONMEM concepts and techniques.
- Ability to communicate clearly, both orally and in writing.
Responsibilities
- Create documentation for regulatory filings, including reviewers guides and data definition documents.
- Participate in the development of standard SAS macros.
- Consolidate heterogeneous data sources, including clinical study databases, external databases, and real-world data, to prepare analysis-ready datasets within a defined quality-control process supporting a study.
- Perform exploratory data analyses and visualizations in interaction with a clinical pharmacologist or pharmacometrician.
- Produce dynamic and static data visualizations to communicate quantitative analyses.
- Develop SAS programs to create ADaM datasets following CDISC standards.
- Develop SAS programs to create Tables, Listings, and Figures.
- Validate ADaM datasets.
- Validate Tables, Listings, and Figures.
- Create specifications for the structure of ADaM datasets for individual studies.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Participation in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
