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Lead the statistical strategy and execution for Phase I–III oncology trials while providing expert guidance on protocols and regulatory submissions. Mentor junior staff and drive continuous process improvement initiatives across clinical programs.
Requires a Master’s degree or PhD in biostatistics or a related field with over 10 years of relevant experience. Candidates must possess strong programming skills in SAS or R and have extensive experience in oncology clinical trials.
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Principal Biostatistician, you will lead the statistical strategy and delivery for Phase I–III oncology trials. You will serve as a key expert across protocols, SAPs, data analysis, and regulatory submissions while mentoring others and driving process improvement.
What You Will Be Doing
• Lead statistical strategy and execution for oncology programs and individual studies
• Review protocols, SAPs, and clinical reporting to ensure scientific and regulatory excellence
• Provide statistical guidance to clients and support agency interactions
• Perform and oversee inferential analyses using SAS and/or R
• Contribute to proposals, bid defenses, and client presentations
• Mentor junior statisticians and support continuous process improvement initiatives
Your Profile
• Master’s degree or PhD with 10+ years of experience in biostatistics or a 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 including support for submissions
• Excellent communication and leadership capabilities with strong prioritization skills
• Experience in a CRO environment preferred
#LI-KT1
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
