Biostatistician II

Icon • Blue Bell, PA

5d • Remote

About The Position

Biostatistician II - United States (Remote) 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 are excited to offer a fantastic opportunity for a Biostatistician II to join ICON's Data Monitoring Committee (DMC) team. In this role, you will collaborate with multiple sponsors, including a primary US-based sponsor, as well as various global sponsors, providing unblinded DMC support across a diverse portfolio of studies. Location: United States (Remote) East Coast Hours

Requirements

• Bachelors, Masters or Ph.D in Biostatistics, Statistics, or a related field
• 3+ years of Biostatistics experience in clinical research (either at a CRO or sponsor)
• Proficiency in statistical concepts, study design, sample size calculations/recalculations, and patient randomization procedures
• Familiarity with statistical analysis plans and the design of statistical tables, figures, and data listings in regulated clinical trial environment
• Advanced ability to plan, supervise, implement, and monitor the statistical processes for multiple clinical studies simultaneously
• Strong organizational skills and ability to prioritize with strong time management skills
• Effective communication and collaboration skills to work with global, cross-functional teams and external clients

Responsibilities

• Writing DMC statistical analysis plans and designing statistical tables and figures for DMC reports
• Presenting analysis plan and statistical outputs during DMC Organizational Meetings
• Attending open and closed sessions of DMC data review meetings; present unblinded statistical summaries during closed sessions
• Write data quality control specifications and utilize relevant computer languages (SAS, R) and software
• Develop and execute analysis programs for interim analyses
• Assist in conducting statistical analyses and interpreting results
• Prepare summary reports of statistical tables and figures for DMC members
• Review and document analysis and programming work for audit trail purposes
• Work within documented standards and maintain project-specific biostatistics files
• Collaborate effectively with ICON project team members, including data management, statistical programming, and clinical research personnel
• Maintain a diverse portfolio of 10-15 individual studies across sponsors and therapeutic areas
• Lead statistical programmers in preparation of statistical outputs
• Embrace ICON's values, culture of process improvement, and commitment to client needs

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
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees