Biostatistician

Biostatistician Overview

• The Biostatistician role offers remote flexibility and focuses on clinical research statistical analysis and project leadership.
• Collaborate with interdisciplinary teams to contribute to drug development and therapeutic advancements.
• Provide statistical oversight, ensuring sound methodologies in study design, data handling, and reporting.
• Mentor and coach less experienced statisticians and programmers to foster professional growth.
• Develop statistical analysis plans, reports, and methodologies for clinical trials and research projects.
• Engage with regulatory agencies, supporting sponsors in new drug applications and compliance.
• Participate in organizational development by contributing to recruitment and evaluation processes.
• Benefit from a comprehensive package including health coverage, retirement plans, and performance-based bonuses.

Biostatistician Key Responsibilities & Duties

• Manage clinical trial programs/projects, providing technical and operational leadership to project teams.
• Ensure statistical methodologies in study design, sample size estimation, and data analysis are robust and compliant.
• Mentor and develop team members, offering technical reviews and expertise.
• Write and peer review statistical analysis plans, reports, and methodologies.
• Validate statistical deliverables, ensuring accuracy and quality before client release.
• Provide statistical consultation for trial results publication and regulatory submissions.
• Interact with regulatory agencies, ensuring compliance with documentation and statistical results.
• Contribute to continuous improvement of statistical and programming governing documents.

Biostatistician Job Requirements

• Master’s degree in statistical science, mathematics, or related fields; Ph.D. preferred.
• Minimum 7 years of relevant experience; exceptional performance required.
• Expertise in statistical methodologies, clinical trial design, and regulatory compliance.
• Proficiency in statistical programming and data analysis tools.
• Strong leadership and mentoring abilities to guide team members effectively.
• Excellent communication skills for collaboration with interdisciplinary teams and regulatory agencies.
• Familiarity with CDISC standards and regulatory requirements for drug development.
• Ability to work remotely while maintaining high productivity and collaboration.