Senior Biostatistician II
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- 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
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biostatisticsinferential statisticsSASRstatistical analysisstatistical methodsstatistical consultingstudy protocolsstatistical analysis plansregulatory submissions
Soft skills
leadershipcommunicationmentoringtime managementprioritizationpresentation skillsorganizational skillsclient-facing skillsteam collaborationprocess improvement
Certifications
Master's degreePh.D