Statistical Programmer II
Company
ICON plc – A global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and treatments.
Job Details
Job Title: Statistical Programmer II
Job Requisition ID: JR151741
Employment Type: Full-time
Work Mode: Office or Home
Location: Bangalore, India
About the Role
ICON is seeking a Statistical Programmer II to join its clinical programming team. In this role, you will develop, validate, and execute statistical programs that support clinical trial analysis, reporting, and regulatory submissions.
You will work closely with biostatisticians and cross-functional teams to ensure accurate implementation of statistical methodologies and high-quality clinical data outputs.
Key Responsibilities
1. Statistical Programming & Analysis Support
Develop, validate, and maintain complex statistical programs using:
SAS
R
Other relevant tools
Support data manipulation, analysis, and clinical reporting activities.
2. Collaboration & Study Support
Work closely with:
Biostatisticians
Clinical development teams
Translate study requirements into programming deliverables.
Ensure accurate implementation of statistical analyses.
3. Regulatory Documentation & Compliance
Prepare and review:
Statistical Analysis Plans (SAPs)
Programming specifications
Derived datasets
Ensure compliance with:
Regulatory requirements
ICH/GCP guidelines
Industry submission standards
4. Data Standards & Submissions
Apply industry standards for clinical data submissions including:
SDTM
CDASH
Define.xml
Metadata standards
Transform vendor data into SDTM datasets.
Support ADaM dataset development (preferred).
5. Quality Assurance & Data Integrity
Ensure accuracy, consistency, and integrity of clinical trial data outputs.
Perform validation and quality checks on programming deliverables.
6. Mentorship & Training
Mentor junior programmers.
Support training on programming practices and clinical data standards.
Required Qualifications
Experience
4+ years of experience in statistical programming using SAS in clinical research.
Technical Skills
Strong expertise in SAS programming across clinical programs or therapeutic areas.
Experience with:
SDTM submissions
Define.xml
CDASH standards
Metadata management
Experience transforming vendor data into SDTM datasets.
Understanding of ADaM (preferred).
Knowledge
Strong understanding of clinical trial data submission standards.
Familiarity with regulatory expectations in clinical programming.
Core Skills
Strong analytical and problem-solving abilities.
Attention to detail and data accuracy.
Ability to work independently and collaboratively.
Good communication skills to work with cross-functional teams.
Employment Requirement
Employment is subject to having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a comprehensive benefits package, which may include:
Competitive salary and performance-based incentives
Health, dental, and vision insurance
Retirement and pension plans
Life and disability coverage
Employee wellness programs
Learning and career development opportunities
Benefits may vary depending on role and location.
Inclusion & Accessibility
ICON is an equal opportunity employer committed to building an inclusive and accessible workplace.
Reasonable accommodations are available during recruitment upon request.
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