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
The Senior Manager, Translational Science Biostatistics will be expected to work independently with minimal supervision, serving as the statistical lead in support of collaborations led by Translational Science to evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this individual primarily will be accountable for the planning and analysis of human biomarker datasets to inform biomarker identification and validation, clinical development and business strategies. As the study statistician, this individual will be accountable for supporting protocol development and study initiation, developing the SAP and TLG shells, creating variable derivation specifications; providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis; independently reviewing CSRs and performing data interpretation; and supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The immediate need is to manage early clinical development studies primarily in support of Translational Science and Clinical Pharmacology related to oncology, with an equal opportunity to work on current and future neurology programs.
Essential Functions
Be responsible for the operational aspects of the groups in support of multiple early clinical development studies.
Provide clinical statistical support for biomarkers and translational science across oncology programs.
Requirements
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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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