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Job Title: Statistical / Senior Statistical Programmer

Location: Remote
Work Schedule: General Shift | 5 Days a Week
Joining: Immediate or within 30 Days
Compensation: Up to ₹25 LPA (can go up to ₹30 LPA based on experience)

Job Summary

We are seeking an experienced Statistical / Senior Statistical Programmer to support end-to-end clinical trial programming activities. The ideal candidate will have strong hands-on experience in statistical programming, regulatory submissions, and advanced analysis datasets, with a particular focus on SAS and R programming, ADaM datasets, and TLF deliverables.

Qualifications

• Bachelor’s or Master’s degree in:
  • Pharmacy (B.Pharm / M.Pharm), OR
  • Life Sciences (BSc / MSc), OR
  • Engineering (BTech / MTech) with Life Sciences, Biotechnology, Biomedical, or related background

Experience Requirements

• 6+ years of experience as a Statistical Programmer
• Strong hands-on experience with SAS programming
• Minimum 2 years of hands-on R programming experience (mandatory)
  • Only R knowledge or certification without hands-on experience will not be acceptable
• Experience working on healthcare / pharma datasets, including Clinical Research and Clinical Data Management

Key Responsibilities

End-to-End Statistical Programming

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

SDTM Programming

• Create SDTM specification documents
• Write programs to generate SDTM datasets
• Convert SDTM datasets into XPT format for validation purposes
• 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
• Use R packages including dplyr, plyr, ggplot2, tidyverse, shiny
• Create production-level statistical programs
• Generate publication-quality graphs
• Work with large clinical datasets
• Perform data cleaning, analysis, and TLF generation

Collaboration & Quality

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

Key Skills

• SAS 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)
• R Programming
• dplyr
• plyr
• ggplot2
• tidyverse
• shiny
• Clinical Data Analysis
• Clinical Research Programming
• Data Validation & QC
• Cross-functional Collaboration