Responsibilities:
Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets.
Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets.
Following specifications, develops algorithms and writes programs to create datasets.
Produces data listings, summary tables and graphs using SAS software.
Independently check data listings, summary tables and graphs.
Imports and exports SAS data.
Assists data management group in performing data edit checks.
Understands and conducts work consistent with GCP, ICH, CFR part , internal SOPs and training, and international regulatory requirements.
Plays an active role in taking project solutions and generalizing them for the Biostatistics group.
Interact with the project statistician...