· Work closely with project manager and biostatistician, data management team, assist in reviewing statistical analysis plan (SAP), study protocol, annotated CRFs, and analysis file specifications, etc, provide high quality statistical programming support for clinical trial projects.
· Develop and validate complex SAS programs, SAS macros to create tables, listings and graphs (TLGs), generate and validate SDTM and ADaM datasets for multiple phase I- V studies, as well as integrated Summary of Safety and Efficacy (ISS/ISE) for FDA submission, and provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation.
· Develop and validate SAS programs for collecting, processing, analyzing and interpreting safety and efficacy data that are collected during clinical trials.
· Perform high quality statistical analyses and technical support for the clinical trial studies using various statistical procedures, statistical theory and SAS/STAT/MACRO/GRAPH /SQL techniques.
· Gather, manipulate, interpret and report safety and efficacy data that are collected during clinical trials, review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of statistical methodology and principles of probability.
· Use statistical techniques to analyze the clinical data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. Also be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other
agencies, communicate with project manager and notify client Alnylam Pharmaceuticals, Inc in a timely manner on any abnormal testing results.
· Participate in preparing clinical study results for FDA submissions using SAS; writing intense QC documentation for every stage of reporting from extraction to the final reporting of the tables.
· In addition, communicate with project manager and other team members, and assist in client Alnylam Pharmaceuticals Inc's inquiries on clinical trial related statistical analysis with developed SAS tools/techniques.
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