Director, Biostatistics
Eisai US
Summary
This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets and coauthoring manuscripts. In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks.
Job description
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
Skills
Biostatistics Skills, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management, Statistical Programming Skills, Vendor Management
Requirements
- Bachelor's degree (Master's preferred) and 10+ years of relevant experience
- 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
- Experience in Life Sciences industry preferred
Benefits
- Annual Incentive Plan
- Long Term Incentive Plan
- Employee benefit programs
Company overview
Eisai US is the American pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a global pharmaceutical company founded in 1941. Headquartered in Nutley, New Jersey, Eisai US operates with a passionate commitment to patient care through its human health care (hhc) philosophy, which places patients and their families at the forefront of all business decisions. The company focuses on two primary therapeutic areas: oncology and neurology, with particular emphasis on dementia-related diseases and neurodegenerative disorders. Eisai US maintains a fully integrated pharmaceutical business model with end-to-end capabilities spanning discovery, development, and marketing. The organization operates commercial and clinical development organizations in New Jersey, discovery labs in Massachusetts and Pennsylvania, and global demand chain operations in Maryland and North Carolina. Notable products in its portfolio include Leqembi (lecanemab) for Alzheimer's disease, Lenvima (lenvatinib) for various cancers, and Aricept (donepezil) for Alzheimer's treatment. With approximately 1,001-5,000 employees in the United States, Eisai US represents a significant presence in the American pharmaceutical landscape, dedicated to addressing unmet medical needs through innovative therapies and comprehensive patient support programs.