Statistical Programmer
Company: ICON plc
Location: Bangalore, India
Work Mode: Office with Flex (Hybrid)
Department: Biostatistics & Statistical Programming
Employment Type: Full-Time
Experience: 5+ years of experience in Statistical Programming within the Clinical Research or CRO industry, with expertise in SAS, R, Python, clinical trial data analysis, and regulatory reporting.
Salary Package: ₹15–24 LPA (Approx., based on current market standards; final compensation depends on candidate experience, programming expertise, and clinical trial exposure.)
Role Overview
The Statistical Programmer is responsible for developing, validating, and maintaining statistical programs to support clinical trial analysis, regulatory submissions, and reporting. The role collaborates closely with Biostatistics and cross-functional teams to ensure high-quality programming deliverables, regulatory compliance, and accurate interpretation of clinical trial data.
Key Responsibilities
Statistical Programming
Develop, validate, and maintain statistical programs using:
SAS
R
Python
R Shiny (preferred)
Perform data manipulation, statistical analysis, and reporting for clinical trials.
Create and validate derived datasets to support statistical analyses.
Ensure programming deliverables are accurate, efficient, and completed within project timelines.
Clinical Trial Data Analysis
Collaborate with Biostatisticians to interpret study protocols and statistical requirements.
Implement statistical analyses based on approved Statistical Analysis Plans (SAPs).
Generate and validate:
Tables
Listings
Figures (TLFs)
Analysis datasets
Review statistical outputs for quality, consistency, and regulatory compliance.
Regulatory Compliance & Documentation
Prepare and review:
Statistical Analysis Plans (SAPs)
Programming specifications
Derived datasets
Validation documentation
Ensure compliance with:
ICH-GCP Guidelines
Regulatory requirements
CDISC standards (SDTM/ADaM preferred)
Company SOPs
Maintain high standards of data integrity throughout the programming lifecycle.
Cross-Functional Collaboration
Work closely with:
Biostatistics
Clinical Data Management
Clinical Operations
Medical Writing
Regulatory Affairs
Participate in project meetings and provide statistical programming expertise.
Support regulatory submissions with accurate statistical outputs.
Communicate technical concepts effectively to cross-functional stakeholders.
Mentoring & Continuous Improvement
Mentor and support junior Statistical Programmers.
Provide guidance on programming standards, validation techniques, and best practices.
Assist in training new team members.
Contribute to process improvement and programming standardization initiatives.
Educational Qualification
Bachelor's degree in:
Statistics
Mathematics
Computer Science
Data Science
Or another related discipline
Preferred: Master's degree or other advanced qualification in a relevant field.
Required Experience
5+ years of Statistical Programming experience within the Clinical Research, Pharmaceutical, Biotechnology, or CRO industry.
Experience supporting global clinical trials and regulatory submissions.
Strong knowledge of statistical methodologies and programming standards.
Experience working with clinical data management systems.
Technical Skills
Advanced proficiency in:
SAS
R
Python
R Shiny (preferred)
Experience with:
Statistical Analysis Plans (SAPs)
Clinical trial datasets
Derived datasets
Tables, Listings & Figures (TLFs)
Clinical data validation
Knowledge of CDISC standards (SDTM and ADaM) is preferred.
Good understanding of ICH-GCP guidelines and global regulatory requirements.
Proficiency in Microsoft Office applications.
Key Competencies
Strong analytical and statistical problem-solving skills.
Excellent programming and validation abilities.
High attention to detail and data accuracy.
Strong communication and collaboration skills.
Ability to work independently and manage multiple projects simultaneously.
Leadership and mentoring capabilities.
Strong organizational and time management skills.
Commitment to quality, compliance, and continuous process improvement.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
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Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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Prague |Chile :
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Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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Warsaw |