SAS Clinical Programmer

Ensure that CRFs being proposed for the study, as well as the options selected, are consistent with other protocols in the project. Review validation document, propose new validations. Review derivation document. Implement required CDER derivations. Create windowing/partitioning document for study. Implement partitioning once study available in Application Framework. Review/UAT e-diaries. Program SAP tables & listings (Local reactions, Systemic Events, AEs, SAEs). Review for adherence to SAP and ensure consistency across tables. Create summary table of exclusionary reasons from populations, listing of subjects excluded. Be able to perform required analyses for efficacy, and/or immunogenicity and/or virology. Program SAP tables & listings (Demography, Disposition, and Adherence to protocol). Co-develop population dataset. Create datasets from TAC/PAC codes obtained from regulatory affairs. Generate reactogenicity & AE datasets. Generate any other required datasets.

Create appropriate snapshots of the data so that (interim) analyses can be performed, IND/NDA reports can be generated, and as needed for annual updates in EU countries. Propose structures for required analytic datasets. Program dummy population file & dummy PAC/TAC files so that programs can be written. Incorporate common problems into Dummy datasets. Review data while programming to ensure program handles accepted problematic data and that the proposed statistical methods are still valid. Propose new validations to handle common problems. Ensure programs list intermediary checking steps.

JOB REQUIREMENTS: