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, PowerPoint, etc.