Statistical Programmer/Analyst III

As a Statistical Programmer, your main responsibilities will include: - Analyzing data and reporting statistical results. - Developing SDTM specifications for programming datasets following CDISC standard. - Independently developing SAS programs to create SDTM datasets. - Developing ADaM analysis data specifications for programming following CDISC standard with minimum supervision. - Independently developing SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan. - Developing, debugging, and maintaining SAS programs and macros to create Tables, Listings, and Graphs for Clinical Study Report following CDISC, industry guidelines, and Statistical Analysis Plan. - Independently implementing SAS programs to generate Define-XML package for FDA submission. - Developing SAS programmable edit checks to assist data monitoring, documenting and reporting data issues to Data Management. - Implementing statistical data analysis and communicating with statisticians for statistical input. - Supporting regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities. - Performing other programming tasks as needed per management requests. Qualifications required for this role: - 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 plans 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. - Valuable understanding of the clinical drug development process. - Team player with strong communication and coordination skills. - Detail-oriented with the ability to learn and adapt to changes. - Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc. As a Statistical Programmer, your main responsibilities will include: - Analyzing data and reporting statistical results. - Developing SDTM specifications for programming datasets following CDISC standard. - Independently developing SAS programs to create SDTM datasets. - Developing ADaM analysis data specifications for programming following CDISC standard with minimum supervision. - Independently developing SAS programs to create ADaM datasets for Analysis and Reporting based on Statistical Analysis Plan. - Developing, debugging, and maintaining SAS programs and macros to create Tables, Listings, and Graphs for Clinical Study Report following CDISC, industry guidelines, and Statistical Analysis Plan. - Independently implementing SAS programs to generate Define-XML package for FDA submission. - Developing SAS programmable edit checks to assist data monitoring, documenting and reporting data issues to Data Management. - Implementing statistical data analysis and communicating with statisticians for statistical input. - Supporting regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities. - Performing other programming tasks as needed per management requests. Qualifications required for this role: - 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 plans 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. - Valuable understanding of the clinical drug development process. - Team player with strong communication and coordination skills. - Detail-oriented with the ability to learn and adapt to changes. - Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.