The Senior Statistical Programmer II provides technical guidance on clinical project teams. Work is performed on the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. In addition, the Senior Statistical Programmer II participates in departmental and cross functional technology development and process improvement initiatives.
Key Duties and Responsibilities:
Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format; consistently meeting objectives of the study
Performs quality control checks of SAS code and output produced by other Statistical Programmers
Demonstrates proficient knowledge of clinical development and medical data
Solves clinical trial reporting problems and has a proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately with limited supervision
Creates CDISC data sets by transforming various raw data sources, including different Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications
Works with all types of coding dictionaries (MedDRA and WHODD) commonly used by the pharmaceutical industry
Works in a team environment providing technical leadership and solving clinical trial reporting problems within budget and customary time line constraints while assuring high quality standards
Knowledge and Skills:
Competence with SAS
Working knowledge of CDISC Standards
Working knowledge of clinical trials
Effective communication (written and verbal) skills to exchange complex information with others
Education and Experience:
Bachelor's/Master's degree in a Scientific Discipline
Typically requires 2+ years for M.S or above. and 5+ years for B.S. of work experience in Biotech, Pharmaceuticals or Clinical Research Organization.
Vertex is a global biotechnology company that invests in scientific innovation.
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