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Statistical Programmer

Icon
ICON
5+ years
Not Disclosed
Bangalore, Chennai, Trivandrum, India
10 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, medical device, and public health organizations in advancing clinical development and improving patient outcomes.


Job Details

Category

Details

Job Title

Statistical Programmer

Company

ICON plc

Department

Biostatistics / Statistical Programming

Industry

Clinical Research / Pharmaceutical / Biotechnology

Employment Type

Full-Time

Experience Required

5+ Years

Education Required

Bachelor’s Degree

Preferred Field

Statistics, Mathematics, Computer Science, or Related Discipline

Preferred Qualification

Advanced Degree (Plus)


Role Summary

The Statistical Programmer is responsible for developing, validating, and maintaining statistical programs used in clinical trial analysis and reporting. The role supports the interpretation of clinical data and ensures the accurate delivery of statistical outputs required for research studies and regulatory submissions.

The position involves close collaboration with biostatisticians and cross-functional teams while ensuring compliance with industry standards and regulatory guidelines.


Key Responsibilities

1. Statistical Programming

  • Develop, validate, and maintain statistical programs using:

    • SAS

    • R

    • Similar programming tools

  • Support:

    • Data manipulation

    • Statistical analysis

    • Clinical trial reporting


2. Clinical Trial Data Analysis

  • Collaborate with biostatisticians and project teams to:

    • Interpret study requirements

    • Implement statistical analyses accurately

  • Support generation of analysis datasets and reporting outputs.


3. Statistical Documentation

  • Prepare and review:

    • Statistical Analysis Plans (SAPs)

    • Programming specifications

    • Derived datasets

  • Ensure outputs meet regulatory and project standards.


4. Regulatory Compliance & Data Integrity

  • Ensure compliance with:

    • ICH-GCP guidelines

    • Regulatory standards

    • Industry best practices

  • Maintain data quality and integrity throughout the programming lifecycle.


5. Team Support & Mentorship

  • Mentor junior statistical programmers.

  • Provide training on:

    • Programming methodologies

    • Best practices

    • Statistical programming standards

  • Support continuous team development.


Required Qualifications

Educational Requirements

  • Bachelor’s Degree in:

    • Statistics

    • Mathematics

    • Computer Science

    • Related field

  • Advanced degree is an advantage.


Experience Requirements

  • Minimum 5 years of experience as a Statistical Programmer within:

    • Clinical research

    • Pharmaceutical industry

    • Biotechnology industry

    • CRO environments


Technical Skills

Programming Languages

  • SAS

  • R

  • Python (Exposure preferred)

  • R Shiny

Additional Technical Knowledge

  • Clinical data management systems

  • Statistical methodologies

  • Clinical trial data standards

  • Dataset derivation and reporting


Regulatory & Industry Knowledge

  • Understanding of:

    • ICH-GCP guidelines

    • Clinical trial processes

    • Regulatory submission standards

    • Statistical programming best practices


Soft Skills

  • Strong analytical and problem-solving abilities

  • Attention to detail

  • Ability to work independently

  • Effective communication skills

  • Collaboration and teamwork capabilities

  • Ability to explain technical concepts to non-technical stakeholders


Preferred Candidate Profile

Ideal candidates may have experience in:

  • Clinical Trial Programming

  • Biostatistics

  • SDTM/ADaM dataset creation

  • TLF (Tables, Listings, Figures) generation

  • Regulatory submissions

  • Statistical reporting automation

  • Clinical Data Analysis

  • CRO or Pharmaceutical environments

  • Data visualization tools


Benefits Offered

Compensation & Rewards

  • Competitive salary package

  • Recognition and performance programs


Health & Wellbeing

  • Comprehensive health insurance options

  • Employee Assistance Programme (TELUS Health)

  • Life assurance coverage

  • Wellness initiatives


Work-Life Balance

  • Annual leave entitlements

  • Flexible employee benefits

  • Family-focused support policies


Financial & Lifestyle Benefits

  • Retirement planning programs

  • Childcare vouchers

  • Bike purchase schemes

  • Discounted gym memberships

  • Subsidized travel passes

  • Health assessments


Diversity & Inclusion

ICON plc is committed to maintaining an inclusive and accessible workplace and provides equal employment opportunities regardless of:

  • Race

  • Religion

  • Gender

  • Sexual orientation

  • Gender identity

  • National origin

  • Disability

  • Veteran status

Reasonable accommodations are available during the recruitment and employment process.