
Principal Biostatistician
Posted 2 days ago

Posted 2 days ago
This is a fully remote position, open to applicants in New Jersey.
• Oversee clinical trial programs and projects for one or multiple clients.
• Deliver daily technical and operational guidance to project teams.
• Provide statistical oversight for projects within assigned drug development programs.
• Ensure robust statistical methodologies in study design, sample size calculation, statistical analysis planning, and reporting.
• Guide, mentor, develop, and offer technical reviews and advice to junior Biostatisticians and Statistical Programmers.
• Contribute to the writing of trial protocols and research proposals.
• Review and provide feedback on clinical data management outputs.
• Prepare Statistical Analysis Plans and Statistical Reports.
• Conduct comprehensive Quality Control reviews on statistical outputs.
• Ensure adherence to applicable regulatory standards.
• Engage with regulatory agencies and assist sponsors in new drug submissions.
• Ph.D. in statistical science, mathematical analysis, or related disciplines with a minimum of 7 years of relevant experience.
• Master’s degree in these areas with at least 10 years of relevant experience.
• Proven exceptional capability and performance.
• Medical, dental, and vision insurance.
• Life and AD&D insurance.
• Short- and long-term disability coverage.
• Tuition reimbursement program.
• Fitness reimbursement options.
• Employee Assistance Program (EAP).
• 401(k) retirement and pension plan.
• Generous paid time off and sick leave.
• Performance-based bonuses.
Alcanza Clinical Research
Thermo Fisher Scientific
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