Principal Biostatistician – Clinical Trials
Company: ICON plc
Job Title: Principal Biostatistician
Job Requisition ID: JR156886
Job Type: Full-time
Locations: Bengaluru / Trivandrum / Chennai, India
Work Model: Office or Home (Flexible)
Experience Required
10+ years of experience in:
Biostatistics
Clinical Trial Statistics
Pharmaceutical Research
Clinical Research Organization (CRO) environment
Preferred Experience:
Leadership experience in Phase I–III oncology clinical trials
Experience managing client interactions and regulatory submissions
Educational Qualification
Candidates should possess:
Master’s Degree in:
Biostatistics
Statistics
Mathematics
Public Health
Related quantitative discipline
OR
PhD in Biostatistics or related field
Department
Biostatistics / Clinical Data Science / Statistical Programming / Clinical Research
Job Summary
ICON is hiring a Principal Biostatistician who will lead statistical strategy and execution for Phase I–III oncology clinical trials. The role involves designing statistical approaches, reviewing clinical trial protocols, developing Statistical Analysis Plans (SAPs), performing advanced analyses, supporting regulatory submissions, and providing statistical expertise to clients and internal teams.
The selected candidate will act as a senior statistical expert, mentor junior statisticians, contribute to business development activities, and drive improvements in statistical processes.
Key Responsibilities
Statistical Strategy & Trial Support
Lead statistical strategy for oncology clinical development programs.
Provide statistical oversight for individual clinical studies.
Support Phase I–III clinical trial designs.
Ensure statistical methods meet scientific and regulatory expectations.
Review clinical trial protocols and provide statistical input.
Data Analysis & Programming
Perform and oversee statistical analyses for clinical trials.
Conduct inferential statistical analysis using:
SAS
R
Review statistical outputs and ensure accuracy.
Support clinical reporting activities.
Ensure analysis methods align with study objectives.
Regulatory & Client Support
Provide statistical guidance to pharmaceutical clients.
Support regulatory submission activities.
Participate in interactions with regulatory agencies.
Review regulatory documents and statistical sections.
Provide scientific input during client discussions.
Leadership & Mentoring
Mentor junior and mid-level statisticians.
Provide technical guidance and knowledge sharing.
Support statistical team development.
Drive continuous process improvement initiatives.
Improve efficiency and quality of statistical deliverables.
Business Development Activities
Contribute to:
Client proposals
Bid defense presentations
Statistical strategy discussions
Present statistical approaches to clients.
Support project acquisition activities.
Required Skills
Clinical Trial Biostatistics
Oncology Clinical Trials
Phase I–III Study Design
Statistical Analysis Plans (SAP)
SAS Programming
R Programming
Statistical Modeling
Clinical Data Analysis
Regulatory Submission Support
FDA/ICH Regulatory Knowledge
Scientific Reporting
Client Management
Team Leadership
Mentoring Skills
Problem Solving
Preferred Skills
Experience working in a CRO environment.
Strong knowledge of oncology therapeutic areas.
Experience leading global clinical trials.
Ability to manage multiple complex projects.
Strong communication and presentation skills.
Experience interacting with pharmaceutical sponsors.
Roles and Responsibilities
Act as the statistical lead for assigned oncology programs.
Ensure high-quality statistical deliverables.
Provide expert statistical consultation.
Review and approve statistical documents.
Support regulatory and scientific decision-making.
Guide statistical teams and improve processes.
Maintain compliance with clinical research standards.
Work Environment
Full-time employment.
Office-based or home-based work option.
Collaboration with global clinical research teams.
Interaction with pharmaceutical sponsors and regulatory stakeholders.
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization focused on accelerating the development of new medicines and treatments. ICON partners with pharmaceutical, biotechnology, and healthcare organizations to conduct clinical trials and deliver healthcare solutions worldwide.
Estimated Salary Package
The official job posting does not disclose salary details. Based on industry standards for Principal Biostatistician roles in India:
|
Experience |
Estimated Annual CTC |
|---|---|
|
10–12 years |
₹25 – ₹40 LPA |
|
12–15 years |
₹35 – ₹55 LPA |
|
Senior oncology statistical leadership |
₹50+ LPA possible |
Expected Average CTC: ₹30–50 LPA, depending on oncology trial expertise, programming skills (SAS/R), leadership experience, CRO background, and ICON compensation structure.
Who Should Apply
Candidates with:
Master’s degree or PhD in Biostatistics/Statistics or related field.
10+ years of clinical trial statistical experience.
Strong oncology Phase I–III trial experience.
Hands-on SAS and/or R programming skills.
Experience with SAP development and regulatory submissions.
Ability to lead teams and communicate with global clients.
Locations
Bengaluru, Karnataka, India
Trivandrum, Kerala, India
Chennai, Tamil Nadu, India
Employment Type
Full-time
Office or Home Work Model
Key Highlights
Senior leadership opportunity in clinical trial biostatistics.
Work on global oncology Phase I–III studies.
Direct involvement in regulatory submissions and client strategy.
Opportunity to mentor statistical teams.
Exposure to advanced clinical research methodologies.
Flexible office/home work arrangement.
Strong career growth pathway within global CRO operations.
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