– 6 month potentially renewable remote contract
Provides statistical programming support for the implementation of data models and the reporting of clinical trials (SDTM-focused).
- Demonstrates advanced knowledge of computer programming, statistical analysis systems (SAS), and other procedural languages.
- Shows solid understanding biometrics procedures, workflows, and software systems.
- Displays ability to manage extremely large datasets for statistical analysis and mathematical model creation.
- Exhibits excellent written and oral communication skills.
- Demonstrates a strong knowledge and understanding of analysis data structure standards (ADaM) and a good understanding of conversion data structure standards (SDTM)
- Applies leadership skills in the coordination of analysis and reporting activities for statistical programming projects.
- SDTM or Tabulation datasets creation and QC
- aCRF creation
- Creation of SDTM define.xml and Study Data Reviewers Guide (SDRG)
- Validate datasets
- Raw Data transfers
- SDTM or Tabulation Data transf
- Bachelor’s degree in a quantitative or scientific field required. Master’s preferred.
- 5-10 experience in SDTM programming with knowledge of latest regulatory expectations
- Excellent written and oral communication skills required.