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Senior Statistical Programmer Ii

Icon Plc
ICON PLC
5-8 years
preferred by company
Bangalore, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Senior Statistical Programmer II

Location: Bangalore, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office or Home (Hybrid / Remote Flexibility)
Industry: Clinical Research | Biostatistics | Statistical Programming | Pharmaceutical | CRO
Department: Clinical Development / Statistical Programming
Job Reference ID: JR151832
Application Deadline: 29 May 2026

Job Overview

ICON plc is hiring a Senior Statistical Programmer II in Bangalore, India for its global clinical development team. This opportunity is ideal for experienced professionals with expertise in SAS programming, statistical programming, clinical trial data analysis, regulatory reporting, biostatistics collaboration, and pharmaceutical clinical research.

The selected candidate will play a critical role in the analysis, validation, and reporting of clinical trial data, ensuring high-quality statistical deliverables that support regulatory submissions and clinical development programs. This is a senior-level role with mentoring responsibilities, making it ideal for professionals seeking leadership growth in clinical programming and biostatistics operations.

Job Responsibilities

Statistical Programming & Clinical Data Analysis

  • Design, develop, and validate SAS programs for clinical trial statistical analysis.
  • Generate high-quality statistical outputs for:
    • Tables
    • Listings
    • Figures (TLFs)
    • Analysis datasets
    • Clinical reports

Ensure statistical outputs are accurate, compliant, and submission-ready.

SAS Programming

  • Develop advanced SAS programming solutions for clinical trial reporting.
  • Optimize programming workflows for efficiency and data integrity.
  • Support automated and repeatable statistical programming processes.

Collaboration with Biostatistics Teams

  • Work closely with biostatisticians to:
    • Develop statistical analysis plans
    • Apply appropriate statistical methodologies
    • Support data interpretation
    • Align programming deliverables with protocol requirements

Quality Control & Validation

  • Perform comprehensive QC checks on statistical outputs.
  • Validate programming deliverables against:
    • Project specifications
    • Regulatory expectations
    • Statistical analysis plans
    • Internal quality standards

Ensure inspection-ready deliverables.

Regulatory Submission Support

Contribute to regulatory documentation including:

  • Clinical study statistical reports
  • Submission-ready datasets
  • Regulatory presentations
  • Clinical development deliverables

Support pharmaceutical submission programs.

Reporting & Scientific Documentation

  • Assist in preparing:
    • Statistical reports
    • Clinical presentations
    • Data summaries
    • Development program reporting outputs

Mentorship & Team Development

  • Mentor junior statistical programmers.
  • Share best practices, technical expertise, and programming standards.
  • Support capability building within the programming team.

Cross-Functional Collaboration

Collaborate with:

  • Biostatisticians
  • Clinical programmers
  • Clinical operations teams
  • Regulatory teams
  • Project managers
  • Global study stakeholders

Support efficient clinical development execution.

Educational Qualification

Candidates must have:

  • Bachelor’s Degree in:
    • Statistics
    • Computer Science
    • Mathematics
    • Biostatistics
    • Related quantitative discipline

Preferred:

  • Advanced degree in relevant technical field

Experience Requirements

  • Minimum 5–8+ years of significant statistical programming experience in:
    • Clinical research
    • CRO
    • Pharmaceutical industry

Freshers are not eligible.

Mandatory experience:

  • Advanced SAS programming
  • Clinical trial statistical reporting
  • Regulatory deliverables
  • Statistical analysis support