Job Description

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.