Senior Statistical Programmer II
Job Title: Senior Statistical Programmer II
Location: Bangalore, India
Work Model: Office or Home (Hybrid/Remote Eligible)
Employment Type: Full-Time
Job Requisition ID: JR151832
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.
Driven by the values of Integrity, Collaboration, Agility, and Inclusion, ICON fosters a culture where employees contribute to meaningful scientific advancements while growing their careers in a supportive environment.
Position Overview
ICON is seeking an experienced Senior Statistical Programmer II to join its Biometrics and Statistical Programming team. In this role, you will be responsible for the development, validation, and maintenance of statistical programming deliverables supporting clinical trials and regulatory submissions.
You will collaborate closely with biostatisticians, data managers, clinical teams, and regulatory stakeholders to ensure the delivery of accurate, compliant, and high-quality statistical outputs. Additionally, you will provide technical mentorship and guidance to junior programmers while contributing to process improvements and best practices across the organization.
Key Responsibilities
Statistical Programming
Design, develop, validate, and maintain SAS programs for:
Clinical trial analyses
Statistical reporting
Data listings
Summary tables
Figures and outputs
Create efficient and reusable programming solutions to support study deliverables.
Ensure programming activities align with project timelines and quality expectations.
Clinical Trial Data Analysis
Collaborate with biostatisticians to implement statistical analysis plans (SAPs).
Apply appropriate statistical methodologies to support clinical research objectives.
Generate analysis datasets and reporting outputs for clinical studies.
Support interpretation and presentation of clinical trial data.
Quality Control & Compliance
Perform quality control (QC) reviews of statistical programming outputs.
Validate datasets, tables, listings, and figures (TLFs).
Ensure compliance with:
CDISC standards (where applicable)
Regulatory requirements
Industry best practices
Company SOPs and quality standards
Identify and resolve data inconsistencies and programming issues.
Regulatory Submission Support
Contribute to the preparation of statistical deliverables for:
Regulatory submissions
Clinical study reports (CSRs)
Integrated summaries
Health authority requests
Ensure all submission-ready outputs meet regulatory expectations and quality standards.
Leadership & Mentorship
Mentor and support junior statistical programmers.
Provide technical guidance on SAS programming techniques and standards.
Share programming best practices and contribute to team capability development.
Assist in reviewing programming deliverables and providing constructive feedback.
Process Improvement
Participate in the development and enhancement of programming standards and workflows.
Promote automation and efficiency in statistical programming processes.
Support continuous improvement initiatives within the Biometrics function.
Required Qualifications
Education
Bachelor’s Degree in:
Statistics
Computer Science
Mathematics
Biostatistics
Data Science
Related Quantitative or Scientific Discipline
Experience
Significant experience in statistical programming within:
Clinical Research Organizations (CROs)
Pharmaceutical companies
Biotechnology organizations
Proven experience supporting clinical trial data analysis and reporting.
Experience working on multiple studies and managing concurrent priorities.
Experience supporting regulatory submissions is preferred.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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