principal Statistical programmer

Principal Statistical Programmer Responsibilities Project lead level activities. Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data. Create CDISC SDTM and ADaM files, SAS export files and Define.xml usage for electronic submission from data received in non-standard form from various sources. Performs data analysis, statistical analysis, generates safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. Review Data Management Plan, Data validation plan and edit check specifications. Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate outputs according to the requirements. Implements and contributes to statistical analysis plans; provides expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. Recognizes inconsistencies and initiates resolution of data problems. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles. Acts independently to determine methods and procedures on new assignments. May provide guidance to other lower level personnel. Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP). Develop SAS coding and table templates for preparing, processing and analyzing clinical data. Create/acquire tools to improve programming efficiency or quality. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Experience with integrated summaries (ISE/ISS) and Clinical Study Reports. Experience Minimum 8 years Pharmaceutical/Biotech programming experience. NDA submission experience and knowledge required. Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat. BS/MS in Statistics, Math or Scientific Discipline. Work Location: Onsite in San Francisco Bay Area, CA #J-18808-Ljbffr Clinvia