Senior Statistical Programmer / Analyst II

Job description

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