Company Description MEDTEK AI is a data science–driven company focused on accelerating drug development and advancing healthcare solutions for global clients. The team includes senior statisticians, data scientists, experts in statistical modeling and programming, specialists in data visualization, and cloud data engineers. MEDTEK AI also works with data lake strategists, regulatory submission professionals, and drug safety consultants to deliver end-to-end support. The company provides services to pharmaceutical and biotech organizations in North America, Japan, and the European Union, offering exposure to international projects and standards. Job Summary: The Principal R Programmer will provide technical leadership in developing, validating, and optimizing R-based statistical programming solutions for clinical trials (Phase I–IV). This role involves designing reusable R frameworks, supporting regulatory submissions, and ensuring compliance with CDISC and global regulatory standards.

Key Responsibilities
• Lead development of R-based statistical analysis and reporting solutions.
• Design and maintain reusable R packages and automation frameworks.
• Develop ADaM datasets, Tables, Listings, and Figures (TLFs) using R.
• Ensure compliance with CDISC standards (SDTM, ADaM).
• Collaborate with Biostatisticians, Data Management, and Clinical teams.
• Support interim analyses, CSR outputs, and regulatory submissions (FDA/EMA).




• Implement validation processes and quality control checks.
• Provide mentorship and technical oversight to R programmers.
• Contribute to innovation, standardization, and process improvements.
• Act as subject matter expert during sponsor discussions and audits (FSP model). Required

Qualifications:
• Master’s/Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or related field.
• 5+ years of experience in clinical statistical programming.
• Advanced expertise in:
• R programming (tidyverse, data, table, ggplot2, Shiny, etc.)
• Clinical trial data structures
• CDISC (SDTM, ADaM)
• TLF generation and automation
• Solid understanding of Phase II/III clinical trials (Oncology preferred).
• Experience leading teams or acting as technical SME. Preferred

Skills:
• Experience with submission-ready outputs and eCTD requirements.
• Knowledge of SAS (dual programming validation environment).
• Experience in FSP/sponsor-dedicated model.
• Familiarity with Git/version control and CI/CD pipelines.
• Exposure to regulatory inspections and audit readiness. Key Competencies:
• Technical Leadership
• Advanced Statistical Programming
• Regulatory Compliance Focus
• Problem-Solving & Innovation
• Client & Stakeholder Communication

📌 R Programmer (Noida)
🏢 Medtek.AI
📍 Noida