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.