Statistical Programmer

Icon Plc

5+ years

Not Disclosed

Bangalore, Chennai, Trivandrum, India

Openings: 1 June 9, 2026

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines

Job Title: Statistical Programmer

Location: Bangalore, Chennai, Trivandrum, India (Office or Home)

Job Type: Full-Time

Company: ICON plc

About ICON

ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and treatments that improve patient outcomes worldwide. Guided by integrity, collaboration, agility, and inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver world-class clinical research solutions across all phases of drug development.

Position Overview

ICON is seeking an experienced Statistical Programmer to join its global Biostatistics and Statistical Programming team. In this role, you will be responsible for developing, validating, and maintaining statistical programming deliverables that support clinical trial analysis, regulatory submissions, and study reporting activities. You will work closely with Biostatisticians, Data Management professionals, Clinical Teams, and Sponsors to ensure the accuracy, quality, and compliance of statistical outputs throughout the clinical development lifecycle.

This position offers an opportunity to contribute to global clinical research programs while utilizing advanced programming and analytical skills to support innovative therapies and regulatory submissions.

Key Responsibilities

Develop, validate, and maintain statistical programs for clinical trial data manipulation, analysis, reporting, and regulatory submissions.
Create and validate analysis datasets, tables, listings, and figures (TLFs) in accordance with study requirements and regulatory standards.
Collaborate with Biostatisticians and cross-functional teams to interpret study protocols, Statistical Analysis Plans (SAPs), and programming specifications.
Review and contribute to the development of Statistical Analysis Plans, programming specifications, and study documentation.
Perform quality control and validation activities to ensure programming accuracy and data integrity.
Support the generation of SDTM and ADaM datasets in compliance with CDISC standards.
Ensure programming deliverables meet project timelines, quality expectations, and regulatory requirements.
Identify and resolve programming issues, data inconsistencies, and process-related challenges.
Support regulatory submissions and responses to health authority requests.
Develop automation tools, programming utilities, and process improvements to enhance operational efficiency.
Mentor junior programmers and provide technical guidance on programming standards, best practices, and validation methodologies.
Participate in departmental initiatives focused on innovation, quality improvement, and operational excellence.

Required Qualifications

Bachelor's degree in Statistics, Mathematics, Computer Science, Data Science, Biostatistics, or a related quantitative discipline.
Minimum 5 years of experience as a Statistical Programmer within the pharmaceutical, biotechnology, CRO, or clinical research industry.
Strong understanding of clinical trial processes, clinical data structures, and statistical methodologies.
Experience working with clinical trial datasets and regulatory submission requirements.
Advanced analytical and problem-solving skills with strong attention to detail.
Ability to work independently while effectively collaborating within cross-functional teams.
Strong written and verbal communication skills.

Technical Skills

SAS Programming
R Programming
Python Programming
R Shiny Development
Clinical Data Analysis
Statistical Programming
SDTM Dataset Development
ADaM Dataset Development
Tables, Listings & Figures (TLFs)
Clinical Reporting
Data Validation & Quality Control
Automation & Process Optimization
Clinical Data Management Systems
Regulatory Submission Support

CDISC & Regulatory Experience

CDISC Standards (SDTM & ADaM)
Statistical Analysis Plan (SAP) Implementation
Regulatory Submission Deliverables
FDA Submission Support
EMA Submission Support
Data Standards Compliance
Validation Documentation
Audit & Inspection Readiness
Clinical Study Reporting

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Statistical Programmer

Job Description

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