Senior Statistical Programmer

About the Role

Looking for a Senior Statistical Programmer with strong hands-on expertise in SAS and R to support end-to-end clinical trial programming activities. The role involves working on SDTM, ADaM, TLFs, and regulatory submissions, collaborating closely with statisticians and clinical teams to deliver high-quality, submission-ready outputs.

Experience Requirements

• 6+ years of experience as a Statistical Programmer
• Strong hands-on SAS programming experience
• Minimum 2 years of hands-on R programming experience (mandatory)
• R-only knowledge or certifications without real project experience will not be considered
• Experience working with healthcare / pharmaceutical datasets
• Strong exposure to Clinical Research and Clinical Data Management

Key Responsibilities

End-to-End Statistical Programming

• Manage the complete programming lifecycle from raw data to submission-ready outputs
• Convert raw data into SDTM datasets as per CDISC standards
• Develop ADaM datasets including derivations, flags, baselines, and treatment groups
• Create Tables, Listings, and Figures (TLFs)
• Perform validation and QC of datasets and outputs
• Support regulatory submissions

SDTM Programming

• Create SDTM specification documents
• Develop programs to generate SDTM datasets
• Convert SDTM datasets into XPT format for validation
• Ensure compliance with CDISC standards

ADaM Programming

• Develop analysis-ready ADaM datasets
• Apply analysis flags and derive parameters
• Follow CDISC ADaM standards

TLF Development

• Generate Tables for efficacy and safety summaries
• Create Listings for patient-level data
• Develop Figures including graphs and plots
• Support Clinical Study Reports (CSR)

Regulatory Submission Support

• Support ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy)
• Assist in NDA / BLA submissions
• Respond to Regulatory Authority Queries (RTQs)

R Programming

• Write optimized R code for clinical data analysis
• Work with R packages such as dplyr, plyr, ggplot2, tidyverse, shiny
• Develop production-level statistical programs
• Generate publication-quality graphs
• Handle large clinical datasets for data cleaning, analysis, and TLF generation

Collaboration & Quality

• Collaborate with statisticians, clinical data management, and cross-functional teams
• Ensure deliverables meet quality standards, timelines, and regulatory requirements
• Contribute to process improvements, documentation, and programming standards

Key Skills

• SAS Programming
• R Programming
• SDTM (CDISC Standards)
• ADaM Dataset Development
• TLF Programming (Tables, Listings, Figures)
• End-to-End Statistical Programming
• Regulatory Submissions
• ISS / ISE
• RTQ Handling
• Clinical Study Reports (CSR)
• Clinical Data Analysis
• Data Validation & QC
• Cross-functional Collaboration