Job Title: Senior Statistical Programmer II
Company: ICON Clinical Research
Location: Bangalore, India
Employment Type: Full-time
Work Mode: Office or Home (Hybrid/Flexible)
Department: Clinical Programming / Biostatistics
Experience Required: 10+ years of Clinical Statistical Programming experience with strong expertise in SAS, CDISC standards, regulatory submissions, and leadership of clinical programming activities.
Education: Bachelor’s or Master’s degree in Statistics, Mathematics, Life Sciences, Computer Science, or a related field.
Salary Package: ₹25–45 LPA (Estimated as per current market standards for Senior Statistical Programmer II roles in India; final compensation depends on SAS expertise, leadership experience, and interview performance.)
Key Responsibilities:
Design, develop, validate, and maintain SAS programs for clinical trial statistical analysis and reporting.
Work closely with Biostatisticians to implement statistical analysis plans.
Generate and review clinical trial outputs including:
Tables
Listings
Figures (TFLs)
Statistical reports
Perform quality control checks to ensure accuracy, consistency, and regulatory compliance.
Support regulatory submission activities and preparation of clinical development documentation.
Develop SAS macros, edit checks, data transformations, and reporting programs.
Apply CDISC standards including SDTM and related regulatory data requirements.
Perform clinical data review and analysis support activities.
Lead programming activities across Phase I–IV clinical trials.
Mentor junior statistical programmers and share technical best practices.
Collaborate with cross-functional teams to deliver high-quality clinical trial outputs.
Required Skills:
Advanced SAS Programming
Clinical Trial Statistical Programming
CDISC SDTM Standards
ADaM Knowledge
Clinical Data Review
LSAF (Legacy Standard Analysis Files)
SAS Macros Development
Data Transformation & Validation
Statistical Reporting
Regulatory Submission Packages
Quality Control (QC)
TFL Programming
Clinical Trial Data Standards
Team Leadership & Mentoring
Stakeholder Management
Preferred Skills:
Experience supporting global regulatory submissions (FDA/EMA).
Strong knowledge of Phase I–IV clinical trials.
Experience leading programming teams and managing study deliverables.
Expertise in developing automation solutions and programming efficiencies.
Strong understanding of clinical development processes and GCP requirements.
Work Location: Bangalore, India
Benefits:
Competitive salary and performance incentives.
Health and wellness benefits.
Medical, insurance, and retirement plans (as applicable).
Learning and development opportunities.
Leadership and career growth pathways.
Opportunity to work on global clinical development programs.
Collaborative environment with international clinical research teams.
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