Senior Statistical Programmer / Analyst III

<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;</li> <li>Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts;</li> <li>Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)</li> <li>Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision.</li> <li>Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges;</li> <li>Serve as 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 initiatives.</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 coordinate project deliverables, timelines and resources.</li> </ul> <p><strong>Skills and Responsibilities:</strong></p> <ul> <li>Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+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>Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.</li> <li>Expert level in applying concept in Artificial Intelligence and Machine Learning in 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 independently.</li> <li>In-depth understanding of clinical drug development process.</li> <li>Detail-oriented and ability to learn and adapt to changes.</li> </ul>