Statistical Programmer/Analyst III

<p><strong>Responsibilities:</strong></p> <ul> <li>Analyze data and report statistical results.&nbsp;</li> <li>Develop SDTM specifications for programming datasets following CDISC standard.</li> <li>Independently develop SAS programs to create SDTM datasets.</li> <li>Develop ADaM analysis data specifications for programming following CDISC standard with minimum supervision.</li> <li>Independently develop SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan.</li> <li>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.</li> <li>Independently implement SAS programs to generate Define-XML package for FDA submission.</li> <li>Develop SAS programmable edit checks to assist data monitoring, document and report data issue to Data Management.</li> <li>Implement statistical data analysis and communicate with statisticians for statistical input.</li> <li>Support regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities.</li> <li>Perform other programming tasks as needed per management requests.<strong> </strong></li> </ul> <p><strong>Skills and Qualifications:</strong></p> <ul> <li>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.</li> <li>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.</li> <li>Ability to translate statistical analysis plan into SAS programming language, to update and fix existing programs.</li> <li>Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.</li> <li>Good understanding of clinical drug development process.</li> <li>Team player, strong communication skills and coordination skills.</li> <li>Detail oriented and ability to learn and adapt to changes.</li> <li>Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.<strong> </strong></li> </ul> <p>&nbsp;</p> <p>&nbsp;</p>