Director, Biostatistics

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.

• 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

• 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

• 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.…