Senior Biostatistician II

Icon Plc • Blue Bell, PA

47d • Remote

About The Position

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 Biostatistician II to join ICON's Full-Service Biostatistics team. The Senior Biostatistician II will lead and oversee small to medium sized and simple to high complex Phase II-III clinical trials. They will provide input to statistical components including protocol, mock shells, SAP text, programmed deliverables and CSR. Location: United States

Requirements

• Master's degree OR Ph.D in Biostatistics, Statistics, or a related field
• 7+ years of biostatistical experience in either a CRO, pharmaceutical, or biotech company
• Experience leading Phase II-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 working in a clinical research organization preferred

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

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees