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.

Job 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.

Essential Functions

1. Reviews protocols and other study documents that are developed in collaborations of business alliances. Leads and oversees interactions with respect to statistical discussions. Provides statistical supports for regulatory submissions in the collaborations. 30%

2. Provides statistical supports for clinical trials and drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; develops, reviews and/or approves study documents such as clinical study protocols, statistical analysis plan, CRF, edit check specification, data management plan, final database validations, final study report. Performs statistical analyses. 10%

3. Influences the proper use of statistics throughout Eisai's oncology business group; contributes to the development of departmental standards and guidelines. 10%

4. Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs. 10%

5. Functions as lead statistician in global registration trials and manages all related statistical activities. 10%

6. Leads and oversees preparations of inputs for regulatory documents and meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses. 10%

7. Comprehensively assesses options and analytical strategies and identify team training needs and recommends solutions. 10%

8. Provides strategic input and supports exploration of methods to improve Biostatistics operational efficiency. 10%

Requirements

• PhD with 10+ years or MS with 15+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment.
• Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
• Experience with CRO oversight and FDA submission preferred.
• Excellent technical writing and verbal communication skills.
• Strong teamwork ability/commitment and individual initiative.
• Strong organizational skills with ability to effectively manage multiple studies.
• Excellent programming skills in SAS or R.

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.

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