Nextrials, Inc. · 1 week ago
Biostatistician II
United States
Full-time
Remote
Mid Level
3+ years expNextrials, Inc. is a leading healthcare intelligence and clinical research organization. They are seeking a Biostatistician II to join their Data Monitoring Committee (DMC) team, where the candidate will provide unblinded DMC support across a diverse portfolio of studies and collaborate with multiple global sponsors.
Health CareMedicalSoftware
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
Qualification
Required
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
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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Company
Nextrials, Inc.
Founded by bio-pharmaceutical researchers in 1999, Nextrials offers today’s most advanced e-clinical tools and services for speeding the delivery of lifesaving drugs and medical devices to market.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2016-03-18Acquired
Leadership Team
J
Jim Rogers
Founder, President and CEO
L
Lecia Shaffer
Clinical Operations
Company data provided by crunchbase