Statistical Programmer II – Clinical Data & Pharmacometrics
Location: Bangalore (India) | Warsaw (Poland) | Johannesburg (South Africa)
Work Model: Office or Home (Hybrid/Remote)
Employment Type: Full-Time
Application Deadline: February 27, 2026
Job ID: JR143346
Company: ICON plc
ThePharmaDaily.com is featuring a global opportunity for a Statistical Programmer II with ICON plc, a leading clinical research organization (CRO) delivering healthcare intelligence and clinical development solutions worldwide. This role is ideal for experienced clinical statistical programmers with expertise in NONMEM, PK/PD datasets, CDISC standards, and regulatory-compliant programming.
Experience Required
Minimum 4+ years of experience in statistical programming within the clinical research, pharmaceutical, or CRO industry, with hands-on expertise in R and SAS programming.
Job Overview
The Statistical Programmer II is responsible for the development, validation, and execution of statistical programs supporting clinical trial analysis, pharmacokinetic/pharmacodynamic (PK/PD) modeling, and regulatory submissions. The role ensures high-quality, compliant datasets aligned with CDISC standards (SDTM/ADaM) and global regulatory guidelines including ICH-GCP.
This position requires strong technical programming capabilities, attention to detail, and cross-functional collaboration with Data Management, Biostatistics, Statistical Programming, and Bioanalytical teams.
Key Responsibilities
Develop and validate statistical programs in compliance with SOPs, WIs, ICH-GCP, and local regulatory requirements
Program and perform quality control (QC) of NONMEM PK/PD datasets derived from SDTM and ADaM datasets
Ensure accurate, complete, and submission-ready NONMEM input datasets for Pharmacometrics Leaders within defined timelines
Conduct QC and follow-up on outsourced NONMEM datasets to maintain data integrity and quality standards
Prepare regulatory submission packages according to internal project management guidelines
Perform QC of customized R packages used for pharmacometric standardization and build testing suites for validation
Maintain inspection readiness through adherence to training and compliance requirements
Collaborate with cross-functional teams including Data Management, Biostatistics, Statistical Programming, and external bioanalytical providers
Support low to medium complexity projects while ensuring timely delivery of programming outputs
Required Qualifications
Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related quantitative discipline (advanced degree preferred)
4+ years of clinical statistical programming experience (R and SAS required)
Demonstrated experience in NONMEM PK/PD dataset programming and QC
Strong knowledge of CDISC standards including SDTM and ADaM
Proficiency in SAS, R, and/or Python within clinical data environments
Solid understanding of pharmacometric workflows and regulatory submission processes
Strong analytical and problem-solving skills with high attention to detail
Ability to communicate complex statistical methodologies to non-technical stakeholders
Core Competencies
Clinical statistical programming
NONMEM dataset development and validation
CDISC (SDTM/ADaM) compliance
Pharmacokinetic and pharmacodynamic modeling support
Regulatory submission readiness
R package testing and quality control
Cross-functional collaboration in global clinical trials
Compensation and Benefits
ICON offers a competitive compensation package aligned with global industry benchmarks. Country-specific benefits focus on employee well-being, financial security, and work-life balance. These may include:
Annual leave entitlements
Comprehensive health insurance options
Retirement savings and pension programs
Life assurance coverage
Global Employee Assistance Programme (TELUS Health)
Flexible optional benefits such as childcare support, gym memberships, travel subsidies, and wellness initiatives
Equal Opportunity Statement
ICON is committed to maintaining an inclusive, accessible, and discrimination-free workplace. 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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