Senior Biostatistician I

ICON plc • Blue Bell, SD

2d • Remote

About The Position

ICON is seeking a Senior Biostatistician I to join its Full-Service Early Phase Biostatistics team. This role leads and oversees early phase clinical trials and contributes to statistical components including protocols, mock-ups and shells, statistical analysis plan (SAP) text, programmed deliverables, and clinical study reports (CSRs). The position is remote in the United States or Mexico.

The Senior Biostatistician I leads statistical work for programs of studies or individual studies of varying complexity, supports client and regulatory-agency interactions, develops and reviews statistical documentation, and conducts programming and statistical analyses. The role also supports junior statisticians and contributes to improvements in internal processes and guidance.

Requirements

• Master’s degree or Ph.D. in Biostatistics, Statistics, or a related field.
• At least 5 years of biostatistical experience in a CRO, pharmaceutical, or biotech company.
• Experience leading studies, including client-facing responsibilities and timeline management.
• Advanced ability to plan, supervise, implement, and monitor statistical processes for multiple clinical studies.
• Effective written and verbal communication skills, with demonstrated leadership ability.
• Ability to prioritize work and strong time-management skills.

Nice To Haves

• Experience working in a clinical research organization.

Responsibilities

• Serve as lead biostatistician for programs of studies or for individual studies ranging from simple to complex.
• Oversee statistical activities supporting ICON’s interactions with clients and regulatory agencies.
• Review and approve statistical methods sections of study protocols.
• Author statistical analysis plans and provide statistical input to reports.
• Program inferential statistics using SAS and/or R.
• Conduct statistical analyses for clients.
• Mentor or provide support to junior statisticians.
• Lead or participate in initiatives to improve internal processes or create new guidance.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior