Description
Senior (SAS) Statistical programmerVacancy overview
Working in house on some of the areas most prestigious CDISC & SAS programming projects you will be part of a team focused primarily on creating CDISC from Raw data sets, working with primarily Oncology, neurology (CNS) and Rare trails in their early phases.
Key technical skills required:
Writing complex SAS programs designed to analyze and report clinical trial data and transform data to CDISC SDTM and ADaM formatsBASE SAS (macros, ODS, SQL), SAS/ACCESS, SAS/STAT, SAS/GRAPH knowlage of Federal Regulations (CRF's) SAS programs to produce integrated analyses and tables for the summary sections of New Drug Applications (NDAs) including ISS and ISE. Develop specifications and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.
Previous experience with:
Performing QC on program code and outputs produced by other team members. Participate in the development of a library of SAS macros for use across multiple projects and in training biostatisticians and other programmers in their implementation. Assisting the Data Managers by writing and testing edit check programs to check the data for syntax errors, logical inconsistencies, and protocol violations, and generate data listings to facilitate data review performed by the clinical data managers. Providing input to the study team in the design of annotated case report forms in conjunction with the clinical data managers
Create define.xml files from metadata files and blankcrf.pdf using Adobe Acrobat.SAS programs to produce analysis datasets in CDISC ADaM or other formats specified by the sponsor. Design and implement quality control (QC) programs to ensure the quality and integrity of statistical programs which are used to generate datasets including CDISC SDTM and ADaM datasets. Performing validation programming to ensure accuracy of stables and compliance with SAP and FDA regulatory requirements.
Excellent communiacaion skills and experience interacting cross functionally is essential
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