Senior Manager Statistical Analysis & Programming, Oncology Eisai Inc. -
Woodcliff Lake, NJ
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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 Summary
The chosen incumbent shall be responsible for providing statistical analysis and programming leadership for oncology clinical studies, accountable for all programming related activities throughout drug development from study design to regulatory filings and publications.
Essential Functions
Responsibilities
1. Work with Statistical Analysis and Programming therapeutic Area Heads to define project operation strategies for Oncology Product Creation Unit (PCU)
2. Assume accountability for statistical analyst and programming support, plan and manage both internal and external statistical programming resources (i.e., contract programmers
and CROs) for multiple compounds in the Oncology PCU
3. Provide statistical programming support for clinical studies, manage and lead the statistical programming efforts for clinical studies and ensure all deliverables are completed with the pre-defined timelines and are of good quality
4. Manage external vendors, CROs and regulatory agencies with regard to dataset and TLG development, electronic reporting and submission requirements
5. Work closely with and fully contribute to Biostatistics operations and planning to define and implement standards and processes
6. Work with the statisticians as well as other functional areas (such as data management, clinical operations, project management) to continuously improve processes
and increase programming efficiency
7. Assist in managing multiple resources within and across groups to meet project deliverables with regard to statistical analyses and programming requirements
8. Manage day-to-day programming team operations and raise issues/concerns to supervisor as appropriate
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 Inc. - 11 months ago
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