[Hiring] Director of Biostatistics @Eisai US

Role Description

This position serves a critical role within the clinical development in that he/she will be responsible for:

• Designing clinical trials
• Performing data analysis
• Supporting regulatory interactions
• Overseeing CRO activities
• Validating TLGs and analysis datasets
• Coauthoring manuscripts

In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks.

Responsibilities include:

• Translating strategic departmental goals into operational goals for the teams, working across different phases of studies, for one or more compounds
• Managing multiple/large/complex biostat projects/studies through operational oversight of deliverables of the team
• Working cross-functionally with internal teams and CROs/vendor teams to drive strategic study design and manage risks
• Functioning as lead statistician in global registration trials and managing all related statistical activities
• Understanding talent capabilities within the biostatistics team and setting up processes to drive development
• Leading global submission activities as a functional and technical expert
• Driving innovative and efficient study design that supports clinical development and regulatory approval
• Leading the evaluation and selection of strategic/large vendor partners
• Contributing to SOPs/templates and working instructions related to EDC studies and FDA requests
• Leading a team of biostatistics experts through goal planning, performance management, engagement, and development

Qualifications

• Bachelor's degree (Master's preferred) and 10+ years of relevant experience
• Experience in Life Sciences industry preferred
• Ph.D. in Biostatistics or related area
• Experience directing multiple complex projects as a subject matter expert in Biostatistics
• Strong publication record demonstrating relevant experience
• Demonstrated experience in applying statistical skills across multiple areas of pharmaceutical biostatistics
• Experience building internal/external networks and contributing as a thought leader
• Experience directly leading/managing a team through operational oversight
• Proven performance in earlier role/comparable role

Requirements

• Biostatistics Skills
• Communication & Cross-functional Influence
• Critical Thinking & Business Agility
• Industry/Regulatory Knowledge
• Mentoring/People Development
• Project Management
• Statistical Programming Skills
• Vendor Management

Benefits

• The annual base salary range for the Director, Biostatistics is from $205,000-$269,100
• This position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan
• Employees are eligible to participate in Company employee benefit programs
• Certain other benefits may be available for this position