Pr Statistical Programmer(SDTM, ADAM, TLF)

Overview

Lead statistical programming for clinical studies, developing and validating SDTM, ADaM, TLF, and related regulatory deliverables. The role supports multiple complex or global projects and provides technical guidance to programming teams.

What you'll do

• Develop SAS or other software programs for tables, listings, graphs, and derived datasets.
• Perform validation programming and resolve discrepancies with project teams.
• Lead statistical programming activities and monitor team deliverables.
• Review statistical analysis plans, mock shells, specifications, annotated CRFs, and database designs.
• Manage timelines and deliverables across multiple concurrent projects.
• Provide CDISC guidance, compliance reviews, and training.
• Contribute to programming standards, tools, macros, and procedures.

What you'll need

• 8+ years of clinical statistical programming experience.
• Strong experience with SDTM, ADaM, and TLF.
• Experience writing SDTM and ADaM specifications.
• Experience with oncology efficacy endpoints and outputs.
• Excellent written and verbal communication skills.
• Experience with R programming.

Nice to have

• Experience submitting work to a regulatory agency.

Details

• Remote in India.
• Minimal travel may be required.
• Immediate joiners are preferred.