Principal Biostatistician

BANGALORE (IN)HYBRIDPOSTED: 9/11/2026
PHARMAFull-time
HIRING ORGANIZATIONICONContract Research Organization (CRO) / Clinical Research / Healthcare Services
ICON

ROLE OVERVIEW

Lead statistical strategy and delivery for Phase I-III oncology trials, serving as a senior statistical expert across protocols, statistical analysis plans, clinical reporting, data analysis and regulatory submissions while mentoring statisticians and supporting process improvement.

ROLE DEFINITION & RESPONSIBILITIES

  • Lead statistical strategy and execution for oncology programmes and individual studies
  • Review protocols, SAPs and clinical reporting for scientific and regulatory quality
  • Provide statistical guidance to clients and support interactions with regulatory agencies
  • Perform and oversee inferential statistical analyses using SAS and/or R
  • Contribute to proposals, bid defences and client presentations
  • Mentor junior statisticians and support continuous process improvement initiatives
Reporting Hierarchy: Reports to senior statistical/clinical development leadership; Provides statistical leadership to study teams and mentors junior statisticians

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Master's degree or PhD in biostatistics or a related discipline
  • 10+ years of experience in biostatistics or related discipline
  • Strong experience leading Phase I-III oncology studies and client engagements
  • Hands-on programming skills in SAS and/or R
  • Knowledge of regulatory processes and submission support
  • Excellent communication, leadership and prioritisation skills

PREFERRED QUALIFICATIONS

  • Experience in a CRO environment
  • Extensive client-facing experience
  • Experience supporting regulatory submissions and agency interactions
  • Experience mentoring statistical teams

REQUIRED VERIFIED SKILLS

Biostatistics
SAS
R
statistical analysis
inferential analysis
Phase I-III clinical trials
oncology
statistical analysis plans
clinical reporting
regulatory submissions
protocol review
client engagement

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Bonus & Equity: Competitive base salary and performance-related incentives
Benefits: Health and wellbeing programmes including applicable medical, dental and vision coverage; retirement and pension plans; life assurance and disability coverage; employee assistance and wellbeing resources; learning and development opportunities
The posting states competitive base salary and performance-related incentives but does not disclose specific salary figures. Benefits and compensation vary by role and location.

ORGANIZATION CONTEXT & CULTURE

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster. The organisation operates across clinical development and research services for pharmaceutical and healthcare customers.

TEAM SIZE: 40,000+ employees
INDUSTRY: Contract Research Organization (CRO) / Clinical Research / Healthcare Services
Culture: ICON highlights integrity, collaboration, agility and inclusion, with an emphasis on scientific excellence, client partnership and patient-focused clinical development.

EXPECTED CAREER ROADMAP

The role can progress toward senior statistical leadership, therapeutic-area statistical leadership, statistical consulting, global biometrics management or broader clinical development leadership within a CRO or pharmaceutical organisation.

APPLICATION ADVISORY

Emphasize 10+ years of biostatistics experience and oncology trial leadership; demonstrate Phase I-III experience; highlight hands-on SAS/R programming; showcase SAP, protocol and clinical reporting expertise; include regulatory submission and client-facing experience; quantify leadership and mentoring responsibilities.

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.