Senior Statistical Programmer/Analyst

📋 Description

• Annotate Case Report Form per FDA/CDISC guidelines.
• Develop SDTM specifications and SAS-based datasets.
• Develop ADaM specifications and SAS datasets per SAP.
• Create Tables, Listings, Graphs, and Patient Profiles for CSR.
• Develop ADaM data, Tables, Listings, Figures for ISS/ISE.
• Prepare FDA submission package (define.xml/define.pdf) per FDA guidelines.

🎯 Requirements

• Bachelor’s/Master’s in Statistics, Math, CS, or related field; 4+ years clinical programming.
• Proficient in SAS, C/C++, Java, R, Python, MATLAB, SQL.
• Decode programming logic and explain to team.
• Apply AI/ML concepts in clinical settings.
• ICH, GCP, regulatory requirements knowledge; clinical trial process.
• Strong communication and coordination; ability to mentor and work with global teams.