clinical SAS programmer
As part of my role I served as core project team lead to coordinate and manage programming activities.
As lead programmer I reviewed SAP as per protocol, reviewed SDTM test/ available data including annotated case report forms against SAP and provided inputs.
Write ADaM specification as per the statistical analysis plan and mock shells.
Create, test, maintain and archive SAS programs, logs and study folder for clinical studies.
Ensured proper documentation of the statistical programs and analysis datasets for future reference.
Perform validation through double programming on outputs.
Following departmental SOPs and relevant regulatory guidelines (e.g. ICH).
Perform the ADaM datasets reconciliation between multiple submissions.
Create safety, primary and secondary efficacy datasets and derived datasets in compliance with CDISC ex. ADSL, ADEX, ADAE, ADLB, ADCM, ADVS etc.
Generate safety and efficacy related TABLES, LISTINGS and GRAPHS (TLG’s).