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.
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. 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 Develop