Responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study's protocol or statistical plans.
- Build SAS datasets from clinical database.
- Develop SAS macros, templates and utilities for data cleaning and reporting.
- Utilize SDTM guidelines to build datasets.
- Communicate with an internal team to create deliverables for pharmaceutical and biotechnology clients.
- Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
- Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.
- Write SAS programs to generate tables, listings, and figures and analysis datasets.
- Review CRF annotations and data specifications.
- Work in tandem with Biostatistics and Data Management member on various clinical projects.
- Identify and edit checks per the data validation plan or data management plan.
- Study management reports using SAS.
- Validate the programmed analysis datasets, tables, listing and figures.
- Perform analyses defined in the statistical analysis.
- Prepare clinical and statistical summary reports.
- Communicate with programming and statistics leads.
- Utilize SAS programming skills within protocol team and perform all programming required for clinical trial analysis and reporting.
- Perform quality control on final reports.
- Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
- Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.