Senior Principal Biostatistician

ICON plc • Burlington, PE

23d • Remote

About The Position

Senior Principal Biostatistician (Oncology Early Phase) - United States Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We have an incredible opportunity for a Senior Principal Biostatistician to join ICON’s Full-Service Emerging Oncology Biotech team. The Senior Principal Biostatistician will lead and oversee small to medium sized and simple to high complex Phase I-II clinical trials. They will provide input to statistical components including protocol, mock shells, SAP text, programmed deliverables, and CSR. Location: Remote United States Canada

Requirements

• Master's degree or Ph.D in Biostatistics, Statistics, or a related field
• 8+ years of biostatistical experience, preferably in a clinical research organization
• Experience leading Phase I/II Oncology 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

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
• Participate in bid defense meetings and make presentations at 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

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees