Statistical Programmer
Job Title: Statistical Programmer
Location: Bangalore, Chennai, or Trivandrum, India
Work Model: Office or Home (Hybrid/Remote Eligible)
Employment Type: Full-Time
Job Requisition ID: JR138352
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and therapies that improve patient outcomes worldwide.
Guided by its core values of Integrity, Collaboration, Agility, and Inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to support clinical development, regulatory submissions, and the successful delivery of clinical research programs.
Position Overview
ICON is seeking an experienced Statistical Programmer to join its Biometrics and Statistical Programming team. In this role, you will be responsible for developing, validating, and maintaining statistical programming deliverables that support clinical trial analysis, reporting, and regulatory submissions.
You will collaborate closely with biostatisticians, clinical teams, data managers, and regulatory stakeholders to ensure high-quality, compliant, and accurate statistical outputs. The role also involves mentoring junior programmers and contributing to process improvements within the statistical programming function.
Key Responsibilities
Statistical Programming & Development
Develop, validate, and maintain statistical programs using:
SAS
R
Other statistical programming tools as required
Create programs for:
Clinical trial data manipulation
Statistical analyses
Data listings
Summary tables
Figures and reports
Ensure programming deliverables meet study and regulatory requirements.
Clinical Data Analysis Support
Collaborate with biostatisticians and study teams to understand protocol and analysis requirements.
Implement statistical methodologies accurately according to study specifications.
Support data interpretation through the generation of high-quality statistical outputs.
Develop derived datasets and analysis-ready data structures.
Statistical Documentation
Prepare and review:
Statistical Analysis Plans (SAPs)
Programming Specifications
Dataset Specifications
Validation Documentation
Ensure all documentation is complete, accurate, and compliant with regulatory expectations.
Regulatory Compliance & Data Integrity
Maintain compliance with:
ICH Guidelines
Good Clinical Practice (GCP)
Regulatory Authority Requirements
Internal SOPs and Quality Standards
Perform validation and quality control checks on programming outputs.
Ensure data integrity throughout the programming and reporting process.
Cross-Functional Collaboration
Work closely with:
Biostatistics Teams
Clinical Operations
Data Management
Regulatory Affairs
Project Management Teams
Participate in study meetings and provide technical programming expertise.
Support timely completion of project deliverables.
Mentorship & Team Development
Mentor junior statistical programmers.
Provide guidance on programming standards, methodologies, and best practices.
Assist with onboarding and technical training activities.
Contribute to team knowledge sharing and process improvement initiatives.
Required Qualifications
Education
Required
Bachelor’s Degree in:
Statistics
Mathematics
Computer Science
Biostatistics
Data Science
Related Quantitative Discipline
Preferred
Master's Degree in a relevant field.
Required Experience
Minimum 5+ years of experience as a Statistical Programmer within:
Clinical Research Organizations (CROs)
Pharmaceutical Companies
Biotechnology Organizations
Experience supporting clinical trial analysis and reporting activities.
Experience working with regulatory-compliant clinical research environments.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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