SAS Programmer + R/Python

Key Responsibilities:

• Create and/ or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets
• Create visualizations
• Experience with R Programming / Python
• Perform development and validation of analysis dataset, tables, listings and figures for both safety and efficacy parameters
• Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions.
• Ensure all programs are compliant with the SOPs and project specific guidelines
• Maintain quality and timelines of programming related deliverables
• Update project related documentation regularly
• Track and follow up on all issues raised.

Additional Activities:

• Assists with quality review of above activities performed by a vendor, as needed.
• Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations.
• Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines.