Statistical Programmers II / Senior Statistical Programmers – R, SAS & R Shiny (Clinical Trials)
Location: Trivandrum, India | Chennai, India
Work Model: Office or Home (Hybrid/Remote Flexibility)
Employment Type: Full-Time
Job ID: JR142451
Company: ICON plc
ThePharmaDaily.com is featuring multiple openings for Statistical Programmers II and Senior Statistical Programmers with ICON plc, a global clinical research organization delivering advanced statistical programming and regulatory-compliant clinical data solutions. These roles are ideal for experienced clinical statistical programmers with strong expertise in R, R Shiny, and SAS within regulated environments.
Experience Required
Statistical Programmer II: Minimum 5+ years of experience in clinical statistical programming within a pharmaceutical, biotechnology, or CRO setting.
Senior Statistical Programmer: 6–8+ years of progressive experience in statistical programming, including leadership or mentoring responsibilities.
Job Overview
Statistical Programmers at ICON are responsible for developing, validating, and delivering high-quality statistical programming outputs that support clinical trial analysis, reporting, and global regulatory submissions. Depending on experience level, candidates will contribute through hands-on programming, collaboration with biostatisticians, and implementation of Statistical Analysis Plans (SAPs).
Senior-level professionals will additionally provide mentorship, technical guidance, and process improvement leadership within the statistical programming function.
Key Responsibilities
Develop and validate statistical programs for clinical trial data analysis using R, R Shiny, and SAS
Collaborate with biostatisticians to interpret study protocols and implement Statistical Analysis Plans accurately
Prepare and review programming specifications, derived datasets, and analysis outputs in compliance with regulatory standards
Generate and validate tables, listings, and figures (TLFs) for regulatory submissions and internal stakeholders
Perform quality control (QC) checks to ensure accuracy, consistency, and data integrity
Ensure compliance with ICH-GCP, regulatory guidelines, and submission standards
Contribute to process enhancements and continuous improvement initiatives within statistical programming
Senior-level candidates: mentor junior programmers and support knowledge-sharing initiatives
Required Qualifications
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related quantitative discipline
5+ years of clinical statistical programming experience (mid to senior level scope)
Strong hands-on expertise in R and SAS programming
Experience with R Shiny for interactive data visualization and reporting is highly preferred
Solid understanding of clinical trial data structures and regulatory standards including ICH and GCP
Strong analytical, problem-solving, and data validation skills
High attention to detail and commitment to quality deliverables
Effective communication skills with the ability to collaborate across technical and non-technical teams
Core Competencies
Clinical statistical programming
R, R Shiny, and SAS development
Regulatory-compliant TLF generation
Statistical Analysis Plan (SAP) implementation
Clinical trial data analysis
Quality control and validation
Cross-functional collaboration in global clinical studies
Compensation and Benefits
ICON offers competitive compensation aligned with industry benchmarks. Country-specific benefits focus on employee well-being, financial security, and work-life balance. Benefits may include:
Annual leave entitlements
Comprehensive health insurance options
Retirement planning programs
Life assurance coverage
Global Employee Assistance Programme (TELUS Health)
Flexible optional benefits such as wellness programs, childcare support, gym memberships, and travel subsidies
Equal Opportunity Statement
ICON is committed to fostering an inclusive and accessible workplace environment. All qualified applicants will receive equal consideration regardless of race, religion, gender, disability, veteran status, or other protected characteristics. Reasonable accommodations are available during the recruitment and employment process.
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