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Statistical Programmer

Icon Plc
ICON PLC
5+ years
preferred by company
Bangalore, Chennai, Trivandrum, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, 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

Statistical Programmer

Location: Bangalore, Chennai, Trivandrum, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office or Home (Hybrid / Remote Flexibility)
Department: Clinical Research / Biostatistics / Statistical Programming
Job Reference ID: JR138352
Industry: Clinical Research | CRO | Pharmaceutical | Biotechnology

Job Overview

ICON plc is hiring an experienced Statistical Programmer to join its global clinical research team in India. This opportunity is ideal for professionals with strong expertise in SAS programming, R programming, clinical trial data analysis, statistical reporting, regulatory compliance, and biostatistics support.

As a Statistical Programmer, you will play a critical role in developing, validating, and maintaining statistical programming deliverables that support global clinical trials. You will work closely with biostatisticians, clinical data teams, and cross-functional stakeholders to ensure accurate analysis, regulatory compliance, and high-quality clinical trial reporting.

This role is best suited for professionals seeking career growth in clinical SAS programming, biostatistics programming, CDISC standards, regulatory submissions, and advanced statistical analytics.

Key Responsibilities

Statistical Programming & Analysis

  • Develop, validate, and maintain complex statistical programs for clinical trial data analysis and reporting.
  • Perform data manipulation, statistical computations, dataset creation, and output generation.
  • Support accurate interpretation of clinical trial data for research deliverables.

Clinical Trial Programming Support

  • Build programming solutions for:
    • Statistical analyses
    • Clinical data reporting
    • Derived datasets
    • Tables, Listings, and Figures (TLFs)
    • Data transformations
    • Regulatory deliverables

Cross-Functional Collaboration

  • Partner with:
    • Biostatisticians
    • Clinical data management teams
    • Clinical operations teams
    • Regulatory stakeholders
    • Programming teams

Translate study requirements into robust programming outputs.

Statistical Documentation Support

  • Assist in preparing and reviewing:
    • Statistical Analysis Plans (SAPs)
    • Programming specifications
    • Dataset documentation
    • Validation documentation
    • Statistical deliverables

Regulatory Compliance & Data Integrity

  • Ensure compliance with:
    • ICH guidelines
    • GCP standards
    • Clinical research regulations
    • Internal SOPs
    • Data quality standards

Maintain complete programming accuracy and audit readiness.

Programming Validation & Quality Control

  • Validate statistical programs for correctness, reproducibility, and compliance.
  • Perform QC reviews of outputs and programming logic.
  • Ensure reliable statistical reporting deliverables.

Mentorship & Team Support

  • Mentor junior statistical programmers.
  • Share best practices in programming methodology and validation standards.
  • Support team capability building and training.

Required Educational Qualifications
Candidates should have:

  • Bachelor’s Degree in:
    • Statistics
    • Mathematics
    • Computer Science
    • Biostatistics
    • Data Science
    • Related quantitative discipline

Preferred:

  • Master’s Degree or advanced qualification

Experience Required

  • Minimum 5+ years of experience
  • Freshers are not eligible

Required industry experience:

  • Clinical research
  • CRO
  • Pharmaceutical
  • Biotechnology

Hands-on experience in:

  • Statistical programming
  • Clinical trial reporting
  • Statistical analysis implementation
  • Regulatory clinical data deliverables