Statistical Programmer/Analyst III - 2 (Bengaluru)

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: - Bachelors/Masters 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 Positive 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. .