Job Description :
Provides statistical programming support for project. Reviews protocols, CRFs, statistical analysis plans, and data submission plans. Develops general SAS application code. Prepares the data package for a regulatory submissions. Validates SAS programs and analysis results. Imports and exports data files. Assists in Quality Control activities. Generates and maintains statistical documentation.
Job Responsibilities
Developing statistical tables, listings, and figures for clinical trials
Design standard programs and macros using study metadata
Design and develop SAS macros, applications, and other tools to expedite SAS programming activities to support different areas of Clinical data review
Develop standard SAS utility macros for developing standard programs
Develop and maintain the programs including testing and organizing the SAS datasets, SAS programs and related documentation
Ensure all programming activities and processes are performed following standard
Functions as the primary point of contact for programming related tasks for assigned study
Under minimum guidance, develops and modifies SAS programs to analyze and evaluate clinical data along with assessing data accuracy and consistency
Develops all extraction programs to create raw datasets related to the study
Validating datasets such as SDTM and ADaM
Develops source and analysis datasets from raw data to support the analysis of clinical trials data
Responsible for creating data specifications to generate source and analysis datasets as per the study requirements
Creates tables, figures, and listings to support clinical study reports and electronic submissions.
Develops, validates and maintains global tools such as SAS macros that increase the efficiency of the programming
Participate in system validation, customization, and integration of new tools and technologies
Good understanding of relational databases such as ORACLE, Knowledge of the EDC system, InForm, and underlying data structure is desirable
Good understanding of system development life cycles, GCP, and related regulatory guidelines
Requirements:
0-2 years of industry experience
Master’s degree or equivalent experience
Basic knowledge in Statistics, Computer Science, Biomedical or related field
Knowledge in developing SDTM specifications, programs, validation, SAS programming skills required in Windows UNIX environment with proficiency in SASBase, SAS Macros, SASGraph, SASSQL
Good communication skills