Principal Biostatistician
By Admin · Biostatistics & Statistical Programming

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
* 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
COMPENSATION & REWARDS
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.
EXPECTED CAREER ROADMAP
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