Senior Biostatistician II

ICON plc • Blue Bell, SD

1d • Remote

About The Position

Senior Biostatistician II - United States 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, in the Non-Oncology Account Group. 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 (Remote) 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

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
• 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
• Regulatory experience (supporting and the handling of regulatory requests, for example: NDA applications)

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

• In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include: 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: Mid Level