Statistical Programmer II / Senior Statistical Programmer – Clinical Research
Job Requisition ID: JR142451
Employment Type: Full Time
Work Mode: Office-Based or Remote (Hybrid/Home Office Eligible)
Locations:
India: Trivandrum, Chennai
(US location excluded as per requirement)
Experience Required:
Statistical Programmer II: 5–7 Years
Senior Statistical Programmer: 8+ Years
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is hiring Statistical Programmer II and Senior Statistical Programmers to support global clinical development programs. These roles are integral to the delivery of high-quality statistical programming for clinical trial analysis, regulatory submissions, and data-driven decision-making.
Depending on experience level, the role involves hands-on statistical programming, cross-functional collaboration with biostatistics teams, and a strong focus on quality, compliance, and process excellence.
Key Responsibilities
Statistical Programming & Analysis
Develop, validate, and maintain statistical programs using SAS, R, and R Shiny to support clinical trial analysis and reporting.
Generate derived datasets, tables, listings, and figures (TLFs) in accordance with approved statistical analysis plans (SAPs).
Prepare and review programming specifications and analysis outputs aligned with regulatory submission standards.
Cross-Functional Collaboration
Work closely with biostatisticians to interpret study requirements and ensure accurate implementation of statistical methodologies.
Support internal stakeholders and regulatory teams by delivering high-quality statistical outputs for submissions and reviews.
Quality, Compliance & Process Improvement
Perform quality control (QC) checks to ensure accuracy, consistency, and data integrity across all deliverables.
Ensure compliance with global regulatory guidelines including ICH, GCP, and CDISC standards.
Contribute to continuous improvement initiatives, standardization, and adoption of best practices in statistical programming.
Leadership Responsibilities (Senior Level)
Mentor and guide junior programmers to enhance technical capability and team performance.
Support knowledge sharing, process optimization, and technical innovation across projects.
Required Qualifications & Experience
Minimum 5+ years of experience in statistical programming within a pharmaceutical, biotechnology, CRO, or clinical research environment.
Strong hands-on experience with SAS and R; R Shiny experience is highly desirable.
Solid understanding of clinical trial data structures, statistical methodologies, and regulatory requirements.
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Data Science, or a related discipline.
Advanced degree is considered an advantage for senior-level roles.
Skills & Competencies
Strong analytical and problem-solving skills with high attention to detail.
Ability to manage multiple deliverables in a regulated, deadline-driven environment.
Excellent communication skills with the ability to collaborate across technical and non-technical teams.
Proven capability to work independently while contributing effectively within global project teams.
Why Join ICON
ICON offers a collaborative and inclusive work environment where innovation, quality, and professional growth are prioritized. Employees benefit from competitive compensation, flexible work arrangements, and comprehensive benefits designed to support well-being and work-life balance.
ICON is an equal opportunity employer committed to diversity, equity, and inclusion. All qualified applicants will receive consideration without discrimination of any kind.
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