The Senior Statistical Programmer will develop SDTM and ADaM datasets, generate clinical study reports, and create FDA submission packages using SAS. The role involves leading programming teams, mentoring staff, and applying clinical research standards to support drug development.
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.