Tech Stack

Description

You will lead programming activities for clinical trial data analysis, including developing SDTM and ADaM datasets, generating tables and listings, and creating electronic submission packages. This role involves mentoring team members and collaborating with statisticians and global teams to ensure high-quality deliverables.

Requirements

• Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, or related field
• 5+ years clinical programming experience
• Expert-level in SAS programming; knowledge of C/C++, Java, R, Python, MATLAB, SQL
• In-depth knowledge of ICH, GCP, clinical trial process and regulatory requirements
• Strong communication and coordination skills

Responsibilities

• Annotate Case Report Form following FDA/CDISC or sponsor guidelines
• Develop SDTM and ADaM specifications and generate datasets using SAS
• Develop Tables, Listings, Graphs, and Patient Profile for Clinical Study Report
• Create electronic submission packages (define.xml/define.pdf) following FDA guidelines
• Serve as programming team lead, providing guidance and mentoring