Senior Statistical Programmer

Erekrut... Recruitment Made Easy; India; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

A leading recruitment firm in India is seeking a Senior Statistical Programmer with over 6 years of experience, particularly in SAS and R, to support clinical trial programming activities. The role includes managing the complete programming lifecycle, developing SDTM and ADaM datasets, and ensuring regulatory compliance. Ideal candidates should have hands-on experience with healthcare datasets and be adept in programming standards. This position offers a chance to significantly contribute to quality reporting in clinical research.

Qualifications

• 6+ years of experience as a Statistical Programmer.
• Minimum 2 years of hands-on R programming experience.
• Experience working with healthcare/pharmaceutical datasets.

Responsibilities

• 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.

Skills

SAS Programming

R Programming

SDTM (CDISC Standards)

ADaM Dataset Development

TLF Programming (Tables, Listings, Figures)

Job description

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
• 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

• 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
• 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)