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Role Description

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.

• 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

Qualifications

• 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
• Experience working in a clinical research organization preferred
• 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

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.