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Assoc Director, Biostatistics - Oncology At Eisai Inc.

Location: Woodcliff Lake, New Jersey

Job Description

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.

Job Description:

The Associate Director, Biostatistics within Oncology independently reviews entire protocols and interfaces with clinicians and other functions to understand study requirements and study design elements including sample size calculations, analysis methods, and study durations etc. for multiple studies

The incumbent develops and/or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. This position supports clinical trial related publications.

The incumbent also provides statistical and validation support for analysis datasets, statistical tables, figures and listings as well as performs and validates statistical analysis. Additionally, this individual will be expected to complete Independent reviews of CSRs and perform data interpretation.

The Associate Director, Biostatistics works with the internal/CRO statisticians and programmers to ensure the highest quality of CRO deliverables and QA of data outputs. This individual will function as lead statistician in global registration trials and manage all related statistical activities which includes leading preparation of inputs for regulatory documents and helping to prepare for meetings with health authorities. This individual will also lead preparation of responses to health authorities including identification and execution of new analysis required for these responses.

The Associate Director, Biostatistics manages contract statisticians in the group and provides mentoring and oversight of the assigned work.

Knowledge/Skills/Abilities Required:

  • PhD with 5+ years or MS with 10+ 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