Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. 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. Apply tot his job