Job Description

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.

• Work with global team or sponsors to support the coordination of project deliverables, timelines and resources; 

Skills and Qualifications

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ 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 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.

• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.