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Senior Biostatistician I / Ii

Icon Plc
ICON PLC
6+ years
preferred by company
Bangalore, Chennai, Trivandrum, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Senior Biostatistician I / II

Location: Bangalore, Chennai, Trivandrum, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office or Home (Hybrid / Remote Flexibility)
Industry: Biostatistics | Clinical Research | Pharmaceutical | Biotechnology | CRO
Department: Biostatistics / Clinical Development
Job Reference ID: JR151271

Job Overview

ICON plc is hiring a Senior Biostatistician I / II in India for its global clinical research and clinical development teams. This opportunity is ideal for experienced professionals with expertise in biostatistics, clinical trial design, statistical analysis, SAS programming, R programming, regulatory submissions, and pharmaceutical clinical research.

The selected candidate will lead biostatistical strategy and execution across clinical development programs, including study design, protocol statistical methodology, analysis planning, regulatory interactions, and client-facing clinical research activities.

This senior-level role is ideal for professionals seeking leadership growth in biostatistics, statistical consulting, clinical development strategy, and global regulatory clinical research.

Job Responsibilities

Clinical Trial Statistical Leadership

  • Serve as lead biostatistician for:
    • Clinical study programs
    • Regulatory submissions
    • Individual clinical studies
    • Multi-study portfolios

Provide end-to-end statistical leadership across simple to complex clinical development projects.

Clinical Trial Design & Statistical Methodology

  • Design robust statistical strategies for clinical trials.
  • Review and approve:
    • Statistical methodology sections of study protocols
    • Statistical Analysis Plans (SAPs)
    • Statistical inputs to clinical reports
    • Clinical analysis documentation

Ensure scientifically sound and regulatory-compliant methodologies.

Statistical Programming & Analysis

Perform statistical programming and analysis using:

  • SAS
  • R

Support:

  • Inferential statistics
  • Clinical data analysis
  • Statistical reporting
  • Dataset interpretation
  • Study outcome evaluation

Regulatory Submission Support

Support regulatory clinical development activities including:

  • NDA applications
  • Regulatory authority interactions
  • Statistical response preparation
  • Submission support documentation
  • Regulatory data interpretation

Ensure submission-ready statistical deliverables.

Client-Facing Statistical Consulting

  • Provide statistical consulting to pharmaceutical, biotech, and CRO clients.
  • Support strategic discussions related to:
    • Study design
    • Statistical methodology
    • Analysis planning
    • Research feasibility

Proposal Development & Budgeting

  • Prepare and approve:
    • Research proposals
    • Statistical consulting plans
    • Project budgets
    • Analytical effort estimates

Support commercial project planning.

Business Development Support

Participate in:

  • Bid defense meetings
  • Client presentations
  • Marketing discussions
  • Proposal support activities
  • Pre-award statistical consultation

Represent ICON’s biostatistics expertise externally.

Team Leadership & Mentorship

  • Mentor junior statisticians and support capability development.
  • Share technical expertise, best practices, and process guidance.
  • Provide leadership across multidisciplinary teams.

Process Improvement & Innovation

  • Lead or support initiatives focused on:
    • Internal process improvements
    • Statistical best practice development
    • New procedural guidance
    • Operational excellence

Educational Qualification

Candidates must have:

  • Master’s Degree
    OR
  • PhD in:
    • Biostatistics
    • Statistics
    • Mathematics
    • Quantitative Sciences
    • Related analytical discipline

Experience Requirements

  • Minimum 6+ years of relevant biostatistics experience
  • Freshers are not eligible

Mandatory experience:

  • CRO / Pharmaceutical / Biotech industry
  • Clinical trial statistical analysis
  • Study leadership
  • Regulatory statistical support

Preferred experience:

  • CRO environment
  • Client-facing statistical leadership
  • Global study management