Principal Biostatistician

Overview

• Lead statistical operations for clinical trials, ensuring robust methodologies and compliance with regulatory standards in a fully remote environment.
• Provide strategic leadership to interdisciplinary teams, driving innovation in drug development and commercialization processes.
• Mentor and develop biostatisticians, fostering growth and enhancing team capabilities in statistical analysis.
• Collaborate with regulatory agencies, ensuring documentation accuracy and adherence to industry standards.
• Contribute to organizational strategies, enhancing operational efficiency and statistical excellence.
• Stay updated on advancements in statistical methodologies and clinical trial regulations.
• Engage in recruitment and development initiatives to build a high-performing biostatistics team.
• Support the design and analysis of complex clinical studies, ensuring impactful outcomes.

Key Responsibilities & Duties

• Develop and oversee statistical analysis plans, ensuring alignment with study objectives and regulatory requirements.
• Validate statistical deliverables, maintaining high quality and accuracy standards.
• Provide expert consultation for trial publications, presentations, and sponsor interactions.
• Manage resources effectively, optimizing team capacity and project timelines.
• Collaborate on protocol design, ensuring statistical rigor and feasibility.
• Enhance governing documents and processes, driving continuous improvement initiatives.
• Support interdisciplinary teams in achieving clinical trial milestones and objectives.
• Foster a culture of innovation and excellence within the biostatistics department.

Job Requirements

• Master’s degree in Statistics or related field; Ph.D. preferred.
• Minimum 7 years of experience in biostatistics, with expertise in clinical trials.
• Proficiency in statistical programming languages and data management tools.
• Strong leadership skills, with experience mentoring and developing teams.
• Excellent communication and collaboration abilities, especially in remote settings.
• Comprehensive knowledge of regulatory requirements and statistical methodologies.
• Proven track record in designing and analyzing complex clinical studies.
• Commitment to continuous learning and professional development.