Principal Biostatistican

In this role, you will lead statistical strategy and execution across complex clinical studies, ensuring high-quality, regulatory-ready outputs and strong methodological rigor throughout the study lifecycle. You will coordinate cross-functional activities and provide statistical oversight for large, multi-site programs.

• Lead statistical input for complex studies, including NDA submissions and multi-protocol programs, ensuring scientific and regulatory compliance
• Develop and review Statistical Analysis Plans (SAPs), protocol statistical sections, and analysis deliverables for consistency and accuracy
• Oversee and validate statistical analyses, including quality checks of outputs and review of tables, figures, and listings (TFLs)
• Support project planning activities, including timelines, milestones, resource allocation, and study execution tracking
• Contribute to DMC activities, including charter development, meetings, and statistical support under senior guidance
• Perform advanced statistical modeling, sample size calculations, and randomization plan development
• Participate in bid defenses, audits, and client-facing scientific discussions for complex studies
• Mentor junior statisticians, review their work, and promote best practices across teams

Requirements

This role requires deep expertise in biostatistics and clinical trial methodology, with strong hands-on programming and leadership experience in regulated research environments. You should be confident working independently on complex studies while guiding others and communicating technical concepts clearly to diverse stakeholders.

• Bachelor’s degree required; Master’s or higher in Biostatistics or related field preferred
• 8+ years of experience in biostatistics or a combination of education and equivalent experience
• Strong proficiency in SAS or equivalent statistical programming tools for clinical data analysis
• Solid understanding of clinical trial processes, regulatory expectations, and statistical methodologies
• Experience developing SAPs, conducting analyses, and contributing to clinical study reports (CSRs)
• Strong knowledge of advanced statistical methods (e.g., survival analysis, regression models, categorical data analysis)
• Proven ability to communicate complex statistical concepts to both technical and non-technical audiences
• Experience mentoring or guiding junior team members in a scientific or clinical research setting
• Strong attention to detail, organizational skills, and ability to manage multiple priorities in parallel

Benefits

• Competitive compensation aligned with experience and industry benchmarks
• Flexible work arrangements, including remote or hybrid options depending on project needs
• Opportunity to work on global, high-impact clinical research programs
• Exposure to NDA-level submissions and complex, innovative study designs
• Professional development through mentoring, training, and scientific collaboration
• Participation in conferences, seminars, and external scientific engagements
• Supportive, research-driven environment focused on innovation and teamwork
• Travel opportunities for client meetings, audits, and training sessions (as required).