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
