Responsibilities;
- Produce/Quality Control (QC) randomization lists (implement randomization plan)
- Create/QC SAS data sets and associated documentation for internal use and for regulatory submission (e.g., CDISC, SDTM and ADaM)
- Annotate/QC annotation of CRFs for submission data sets and publishing of annotated CRFs
- Produce/QC TFLs from mock shells
- Review CRFs and eCRFs for programming implementation
- Review EDC data export downloads for compliance with export specifications
- Perform EDC user acceptance testing (UAT) for programming implementation
- Maintain awareness of developments (e.g., version differences, enhancements, changes) within SAS software
Requirements;
- MSc/PhD in Statistics, or equivalent
- 5+ years experience in clinical trials
- Proficient in SAS with a good basis of knowledge of statistical procedures.
- SAS Base Programming Certificate
