Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since then we have rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.
Eisai recognizes that we are the Company’s greatest asset. To this, Eisai is committed to providing us an enabling and empowering work environment that allows us to grow and thrive. In our diverse organization, we adhere to a strict commitment to our values of Integrity, Respect, Professionalism, Quality and Teamwork. We therefore invite you to explore this job opportunity or any others that may match your qualifications and interests.
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 data sets and coauthoring manuscripts. In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks.
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.
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.
3. Influences the proper use of statistics throughout Eisai's neurology business group; contributes to the development of departmental standards and guidelines.
4. Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs.
5. Functions as lead statistician in global registration trials and manages all related statistical activities.
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.
7. Comprehensively assesses options and analytical strategies and identify team training needs and recommends solutions.
8. Provides strategic input and supports exploration of methods to improve Biostatistics operational efficiency.
* 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.
Here at Eisai, we are rewarded with highly competitive salaries, incentive awards, a comprehensive benefits package (Medical, Dental, Prescription and Vision Plans) 401k, Flexible Spending Accounts, Life and Disability Insurance, and other great programs.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai’s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer - Minority / Female / Disability / Vet from tblHiringOrgDefaults
To apply for this position, please copy and paste the following link into your browser address bar: https://eisai.contacthr.com/71629336