Principal Biostatistician

ICON plc • Blue Bell, SD

8d • Remote

About The Position

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. 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.

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
• 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

Nice To Haves

• Experience with Oncology, Rare Disease, Infectious Disease/Vaccine, and/or Cardio-Metabolic Disorders
• Experience working in a clinical research organization

Responsibilities

• 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

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree