StatisticalProgrammer/AnalystIII-2

Responsibilities: Analyze data and report statistical results. Develop SDTM specifications for programming datasets following CDISC standard. Independently develop SAS programs to create SDTM datasets. Develop ADaM analysis data specifications for programming following CDISC standard with minimum supervision. Independently develop SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan. Develop, debug, and maintain SAS programs and macros to create Tables, Listings and Graphs for Clinical Study Report following CDISC, industry guidelines and Statistical Analysis Plan. Independently implement SAS programs to generate Define-XML package for FDA submission. Develop SAS programmable edit checks to assist data monitoring, document and report data issue to Data Management. Implement statistical data analysis and communicate with statisticians for statistical input. Support regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities. Perform other programming tasks as needed per management requests. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 2+ years of statistical programming experience required. Proven knowledge and training in high level computing languages such as SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Ability to translate statistical analysis plan into SAS programming language, to update and fix existing programs. Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understanding of clinical drug development process. Team player, strong communication skills and coordination skills. Detail oriented and ability to learn and adapt to changes. Proficient in Microsoft Office Suite, e.g., Word, Excel, Power