Senior Statistical Programmer (R)

Experienced SAS & R Programmer

Location: Bangalore/Hyderabad/Remote

Experience Required: 6+ years of Statistical Programming experience [R Programming]

Key Responsibilities:

• Perform consistency review of clinical trial documents including Protocols, SAPs, CRFs, and CSRs.
• Author and review simple and complex TFL shells, dataset specifications, and dataset standards (SDTM/ADaM).
• Program, validate, and QC datasets, tables, listings, and figures using SAS and R according to study specifications and programming standards.
• Conduct data exploration and quality checks using frequencies, descriptive statistics, histograms, and other analytical techniques.
• Review and resolve CDISC validation findings and ensure compliance with regulatory, client, and company standards.
• Apply statistical methods such as t-tests, ANOVA, regression, and survival analysis to support study objectives.
• Develop reproducible R programming workflows, automated reporting solutions, data visualizations, and statistical analyses.
• Create and maintain reusable SAS macros, R functions, and programming utilities to improve efficiency and standardization.
• Collaborate with Biostatistics, Data Management, Clinical Operations, and cross-functional teams to deliver study milestones.
• Review project documentation, maintain study master files, and ensure all deliverables are audit and inspection ready.
• Participate in code reviews, quality improvement initiatives, and implementation of programming best practices.
• Support regulatory submissions and ensure high-quality, compliant, and timely delivery of programming outputs.

Required Qualifications:

• Strong expertise in both SAS and R Programming is a must
• Experience developing, validating, and QC'ing clinical datasets, TFLs, and statistical outputs.
• Proficiency with R packages such as tidyverse, ggplot2, survival, and R Markdown/Quarto.
• Good understanding of CDISC standards (SDTM/ADaM) and clinical trial data workflows.
• Experience reviewing technical specifications, requirements, and programming deliverables.
• Strong troubleshooting, debugging, and performance optimization skills.
• Knowledge of validation processes, test case development, and QC documentation.
• Strong communication and collaboration skills, with the ability to work effectively across cross-functional teams.
• Ability to independently analyze requirements and design scalable programming solutions.