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Your Role
Programs all tables, listings and graphs necessary for an assigned clinical study report (CSR);
Programs customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies;
Writes code using Base SAS programs, SAS procedures, or standardized macros;
Analyzes protocol, SAP, existing shells/templates as needed to understand structure and content of data;
Performs data checks as needed, to ensure integrity and correctness of data displays;
Prepares documentation for programs;
Prepares documentation describing all datasets and variables within, including derived variables, and the project as a whole;
Creates SAS datasets of clinical data from clinical databases;
Creates status and efficacy datasets;
Creates project-specific macros and formats;
Loads client data from other platforms and other software packages;
Prepares data to be sent to clients and as needed for other external transfers and data imports.
Your Profile
Communicate effectively in English, in both writing and verbal.
Learn quickly and pay attention to details.
Manage multiple tasks/projects, effectively prioritize and execute tasks, and make quality and on time deliveries.
Work collaboratively, effectively, and productively in diverse organizational structures, and in interaction with dynamic clients.
Work independently, takes ownership and strives for quality and efficiency.
Work positively in a continually changing environment.
Solid/Advanced SAS skills and understanding of the concept of standardization in data, programming, and statistical reporting of trial results and its implication to drug development.
Must Have
At least 5 years experience ADaM/TLF;
Work in detail (e.g during programming, try to identify any issues on spec/sap/shell instead of just following; identify inconsistency between spec/sap/TLF.);
Good at SAS syntax and SAS macro;
Has experience on safety ADaM/TLF production side instead of validation side;
Has some knowledge on ADaM CDISC guidline
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