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; Analyze information and develop innovative solutions to programming and data analysis challenges
Requirements:
Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 3 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 Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
Text:
Senior Statistical Programmer/Analyst 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; Analyze information and develop innovative solutions to programming and data analysis challenges Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 3 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 Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
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