Senior Statistical Programmer/Analyst

<p><strong>Job Description</strong></p> <p><strong>Responsibilities</strong></p> <ul> <li>Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.</li> <li>Develop SDTM specifications and generate SDTM datasets using SAS.</li> <li>Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.&nbsp;</li> <li>Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.&nbsp;</li> <li>Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).&nbsp;</li> <li>Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.</li> <li>Proficient in analyze information and develop innovative solutions to programming and data analysis challenges.</li> <li>Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation.</li> <li>Follow and reinforce regulatory agency requirements during daily job.</li> <li>Serve as a programming team lead and contribute to department initiative.</li> <li>Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.</li> <li>Review draft and final production deliverables for project to ensure quality and consistency.</li> <li>Work with global team or sponsors to support the coordination of project deliverables, timelines and resources;&nbsp;</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 at least 4+ years of clinical programming experience.</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>Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.</li> <li>Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.</li> <li>In-depth knowledge of ICH, 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>Strong communication skills and coordination skills. ability to communicate with global teams with supervision.</li> <li>Good understanding of clinical drug development process.</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.</li> </ul>