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 packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision.
- Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges;
- Serve as 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 initiatives.
- 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.
- Work with global team or sponsors to coordinate project deliverables, timelines and resources.
Skills and Responsibilities:
- Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+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.
- Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
- Expert level in applying concept in Artificial Intelligence and Machine Learning in 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 independently.
- In-depth understanding of clinical drug development process.
- Detail-oriented and ability to learn and adapt to changes.
