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 biostatic 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 Qualifications: Ph.D. in Biostatistics or related area with 9 years relevant experience or Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred. 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 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 At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn. All data that is entered should be in the correct case, please refrain from using all caps. For a better user experience, we recommend using the latest version of Chrome.

Director, Biostatistics.

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