Director, Biostatistics

🔥 19 hours ago

🇺🇸 United States – Remote

💵 $205k - $269.1k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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Eisai US

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1995

💊 Pharmaceuticals

🏥 Healthcare

Pharmaceuticals • Healthcare

Eisai US is the United States arm of Eisai Inc. , a global pharmaceutical company focused on researching, developing, manufacturing and commercializing medicines — particularly in neurology (including Alzheimer’s disease) and oncology. With nearly 40 years of U. S. R&D and manufacturing presence, Eisai US runs clinical trials, patient support programs, community involvement and corporate responsibility initiatives under its “human health care” mission, and emphasizes a science-driven pipeline and collaborations to address areas of high medical need.

📋 Description

• Design clinical trials • Perform data analysis • Support regulatory interactions • Oversee CRO activities • Validate TLGs and analysis datasets • Coauthor manuscripts • Work with statisticians on process development, internal contractor oversight, and team management and development • Translate strategic departmental goals into operational goals for teams across study phases and compounds • Manage multiple, large, and complex biostatistics projects through operational oversight of deliverables • Develop and review study documents, statistical analysis plans, and final study reports • Collaborate with clinical, project management, data management, CRO, and vendor teams • Serve as lead statistician in global registration trials • Establish processes to develop biostatistics team talent • Lead global submission activities and support submission strategy and regulatory communications • Develop innovative and efficient study designs supporting clinical development and regulatory approval • Lead evaluation and selection of strategic and large vendor partners • Contribute to SOPs, templates, and work instructions related to EDC studies, FDA requests, independent validation, and biostatistics processes • Lead biostatistics experts through goal planning, performance management, engagement, and development • Support budget management for the area

🎯 Requirements

• 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 in Biostatistics • Strong publication record demonstrating relevant experience • Demonstrated experience applying statistical skills across multiple areas of pharmaceutical biostatistics • Broad understanding and experience of the clinical development process • Experience building internal/external networks and contributing as a thought leader • (People Leaders/Directors) Experience directly leading/managing a team through operational oversight, including budget and resources • Proven performance in an earlier or comparable role • Biostatistics skills • Communication and cross-functional influence • Critical thinking and business agility • Industry/regulatory knowledge • Mentoring/people development • Project management • Statistical programming skills • Vendor management • Participation in E-Verify and employment eligibility verification for new hires in the United States

🏖️ Benefits

• Eisai Inc. Annual Incentive Plan • Eisai Inc. Long Term Incentive Plan • Company employee benefit programs • Certain other benefits may be available for this position