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.