- PCS / Clinical Protocol Development - reviews whole protocols and interfaces with clinical pharmacologists and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration, etc.
- Statistical Analysis Plan - develops SAPs, TLG shells and specifications of variable derivation.
- Monitoring - develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed).
- Clinical Study Report - provides statistical and validation support for analysis datasets, statistical tables, figures and listings performs and validates statistical analysis; independently reviews CSRs and performs data interpretation.
- Regulatory interaction - supports preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities; drafts responses to health authorities including execution of new analysis required for responses.
- Resource Management - enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team; may manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.
- Statistical lead in support of collaborations led by Translational Science to evaluate biomarkers across oncology programs.
- Assist in planning and analysis of human biomarker datasets to inform biomarker identification and validation, clinical development and business strategies.
- Support efforts of Translational Science to generate useful human biomarker data sets from internal (e.g. clinical samples, purchased samples, etc.) and external sources, as well as promote data and information collection and sharing across oncology programs.
- Statistical lead of biomarker analyses and related activities of individual clinical programs.
- PhD strongly preferred but combination of education and experience may be considered in lieu of PhD.
- Experience in translational medicine and clinical development in industry setting a must; experience in clinical pharmacology and/or data science a plus.
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Senior Manager, Translational Science Biostatistics - Nutley, United States - Eisai, Inc.
Description
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.
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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