Senior Biostatistician II

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

Your profile:

• 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

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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