Lead Data Statistician

5 days ago


rajkot, India beBeeDataScientist Full time

Job SummaryCytel is seeking a highly experienced Principal Statistical Programmer to work with one of our global pharmaceutical clients. As a key member of the team, you will be responsible for implementing reporting and analysis activities for clinical trials.Main Responsibilities:Develop SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studiesCreate SAS programs which generate datasets, complex listings, tables and graphsDeliver high-quality statistical programming resultsSupport clinical study reports, regulatory submissions and publicationsUnderstand and follow FDA regulations affecting clinical trial data reportingAbout YouTo succeed in this role, you will have:Bachelor's degree in computer science, data science, mathematics or statistics major7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical DevelopmentExceptional SAS programming skills and expertise in CDISC standards, medical terminology and clinical trial methodologiesExperience supporting regulatory submissions and interacting with the FDA



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