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. The Senior Manager, Biostatistics – Neuroscience works independently with minimal supervision and serves as a clinical study statistician. He/she will have strong later phase clinical study experience, ideally FDA submissions (NDA) experience, and has collaborated with team members and managers in support of initiatives and programs.
The Senior Manager will be accountable for:
- Supporting protocol development and study initiation
- Developing SAP, TLG shells, specification of variable derivation, SQS plan and DMC charter
- Providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis, independently reviewing CSRs and performing data interpretation
- Supporting preparation of inputs for regulatory documents
- Drafting responses to health authorities including execution of new analysis required for responses
- Managing CROs
- PhD with at least 4 years of experience; or MS with at least 6 years of experience in biostatistics in the pharmaceutical industry/CRO environment required
- Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process
- Strong ability to work in a dynamic environment where multi-tasking and changing priorities exist
- Experience with CRO oversight and FDA submissions strongly preferred
- Excellent technical writing and verbal communication skills
- Strong teamwork ability/commitment and individual initiative
- Strong organizational skills with ability to effectively manage multiple tasks
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
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