Principal Biostatistician
ICON plc
Summary
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
Job description
We have an incredible opportunity for a Principal Biostatistician to join ICON’s Full-Service Biostatistics team. The Principal Biostatistician will lead and oversee small to medium sized and simple to high complex Phase I-III clinical trials. They will provide input to statistical components including protocol, mock shells, SAP text, programmed deliverables and CSR.
What you will be doing:
- Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies
- Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies
- Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports
- Program using SAS and/or R for inferential statistics
- Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients
- Participate in bid defense meetings and make presentations at marketing meetings with prospective clients
- Mentor or provide support to junior statisticians
- Lead or partake in initiatives to improve internal processes or create new guidance
Your profile:
- Master's degree OR Ph.D in Biostatistics, Statistics, or a related field
- 9+ years of biostatistical experience with Master’s degree OR 7+ years of biostatistical experience with Ph.D
- Experience leading Phase I-III studies, including client facing responsibilities, timeline management, and resource oversight
- Experience with Oncology, Rare Disease, Infectious Disease/Vaccine, and/or Cardio-Metabolic Disorders (preferred)
- Experience working in a clinical research organization (preferred)
- Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications)
- Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies
- Effective written and oral communication skills with demonstrated leadership ability
- Ability to prioritize with strong time management skills
Requirements
- Master's degree OR Ph.D in Biostatistics, Statistics, or a related field
- 9+ years of biostatistical experience with Master’s degree OR 7+ years of biostatistical experience with Ph.D
- Experience leading Phase I-III studies, including client facing responsibilities, timeline management, and resource oversight
- Experience with Oncology, Rare Disease, Infectious Disease/Vaccine, and/or Cardio-Metabolic Disorders (preferred)
- Experience working in a clinical research organization (preferred)
- Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications)
- Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies
- Effective written and oral communication skills with demonstrated leadership ability
- Ability to prioritize with strong time management skills
Benefits
- Competitive base salary
- Performance related incentives
- Medical coverage
- Dental coverage
- Vision coverage
- Retirement plans
- Pension plans
- Life assurance
- Disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning and development opportunities
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.