About the role
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. • Minimum of 4+ years of clinical programming experience, along with 1+ year of project management and 1+ year of people management 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.
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