Director, Biostatistics

Eisai US; Nutley (NJ); On-site; USD 205,000 - 269,000; Full time

Job summary

Eisai US is seeking a senior biostatistician to lead a team of biostatistics experts in global registration trials and regulatory submissions. The role involves cross-functional collaboration with clinical, data management, and CRO/vendor teams to drive study design, risk management, and statistical strategy.

Ideal candidates will have a PhD in Biostatistics, 10+ years in Life Sciences, and a proven track record of leadership, publication, and end-to-end project execution within pharmaceutical

Qualifications

• NCH Life Sciences/biostatistics expertise required for global registration studies.
• Strong publication record and ability to lead multiple large, cross-functional projects.
• Experience directing teams, budgets, and resources in a biostatistics context.

Responsibilities

• Translate departmental goals into operational objectives for biostatistics teams.
• Serve as lead statistician on global registration trials and oversee all statistical activities.
• Collaborate with clinical, data management, and CRO/vendor teams to drive study design and risk management.
• Lead submission strategies and regulatory communications.

Skills

Biostatistics

Leadership

Clinical development

Statistical programming

Project management

Regulatory knowledge

Mentoring/People development

Vendor management

Communication

Education

Ph.D. in Biostatistics

Bachelor's degree (Master's preferred)

Job description

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Responsibilities

• Translate the strategic departmental goals into operational goals for the teams, working across different phases of studies, for one or more compound
• Manage multiple/large/complex biostat projects/ studies through operational oversight of deliverables of the team i.e validate TLGs and analysis datasets, coauthor manuscripts, support regulatory interaction, develop/ review of study documents, statistical analysis plan, final study report etc.
• Work cross-functionally with internal cross functional teams (i.e clinical, project management, data management etc.) and CROs/ vendor teams to drive strategic study design, collaboration, proactively managing risks etc.
• Function as lead statistician in global registration trials and manage all related statistical activities
• Understand the talent capabilities within biostatistics team and set up processes to drive development
• Lead global submission activities, acting as a functional and technical expert to support submission strategy planning and regulatory communication
• Drive innovative and efficient study design by developing study designs that address study objectives and support clinical development & regulatory approval
• Lead the evaluation and selection of strategic/ large vendor partners while ensuring synergies and operational efficiency
• Contribute to SOPs/ templates/ and working instructions related to EDC studies, FDA requests, independent validation, and general biostatistic processes
• (People Leaders/ Directors) Lead a team of biostatistics experts through goal planning, performance management, engagement and development of the team; Support in budget management for own area

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 from end to end as a subject matter expert for own area (immunogenicity, biomarkers, safety etc.) in Biostatistics
• Strong publication record demonstrating relevant experience
• Demonstrated experience in applying statistical skills across multiple areas of pharmaceutical biostatistics, with broad understanding and experience of the clinical development process
• Experience building internal/ external networks and contributing as thought leader in own area
• (People Leaders/ Directors) Experience directly leading/managing a team through operational oversight including budget & resources
• Proven performance in earlier role/comparable role

Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred.

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

Eisai Salary Transparency Language

• The annual base salary range for the Director, Biostatistics is from :$205,000-$269,100
• Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
• Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
• Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
• Certain other benefits may be available for this position, please discuss any questions with your recruiter.
• Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
• Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
• Right To Work
• E-Verify Participation