Senior Manager, Translational Science Biostatistics

2 months ago

Nutley, United States Eisai US Full time

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.

* 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.

Provide clinical statistical support for biomarkers and translational science across oncology programs.

* 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.

Requirements

* 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.

#LI-TS1

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.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work

E-Verify Participation

  • Senior Manager, Translational Science Biostatistics

    2 months ago

    Nutley, United States Eisai, Inc. Full time

    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...

  • Senior Manager, Translational Science Biostatistics

    3 weeks ago

    Nutley, United States Eisai, Inc. Full time

    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...

  • Senior Research Associate

    1 month ago

    Nutley, United States Hackensack Meridian Health Full time

    Overview The Senior Research Associate, CDI will work under the guidance of Member Scientist, Assistant Member or Mgr, Associate Member to prepare data for presentations, progress reports and actively participate in the preparation of manuscripts and grant applications. This role will also work independently and take responsibility in the development...

  • Senior Research Associate

    3 weeks ago

    Nutley, United States Hackensack Meridian Health Full time

    Overview The Senior Research Associate, CDI will work under the guidance of Member Scientist, Assistant Member or Mgr, Associate Member to prepare data for presentations, progress reports and actively participate in the preparation of manuscripts and grant applications. This role will also work independently and take responsibility in the development...

  • Health Sciences Librarian

    1 month ago

    Nutley, United States Seton Hall University Full time

    Seton Hall University Libraries invites applications for two (2) full-time permanent Inter-professional Health Sciences (IHS) Library faculty positions. Reporting directly to the Dean of University Libraries, successful candidates will serve as liaisons to the School of Health and Medical Sciences (SHMS) and the College of Nursing (CON) as a team with...

  • Health Sciences Librarian

    3 weeks ago

    Nutley, United States Seton Hall University Full time

    Seton Hall University Libraries invites applications for two (2) full-time permanent Inter-professional Health Sciences (IHS) Library faculty positions. Reporting directly to the Dean of University Libraries, successful candidates will serve as liaisons to the School of Health and Medical Sciences (SHMS) and the College of Nursing (CON) as a team with...

  • Health Sciences Librarian

    5 days ago

    Nutley, New Jersey, United States Seton Hall University Full time

    Provide faculty and student instruction, consultation and support in allied health disciplines including citation management, evidence-based practice, instructional support, interlibrary loan and & document delivery, NIH Public Access Policy, Data Ma Health Science, Librarian, Health, Science, Data Services, Project Management, Education

  • Health Sciences Librarian

    2 months ago

    Nutley, United States Seton Hall University Full time

    Provide faculty and student instruction, consultation and support in allied health disciplines including citation management, evidence-based practice, instructional support, interlibrary loan and & document delivery, NIH Public Access Policy, Data Ma Health Science, Librarian, Health, Science, Data Services, Project Management, Education

  • Research Assistant, Cpc

    6 days ago

    Nutley, United States Hackensack Meridian Health Full time

    Overview: The **Research Assistant, CPC** will be responsible for the day-to-day completion of tasks necessary for the success of an assigned behavioral science research project or set of related projects performed by or in conjunction with the Cancer Prevention and Control Program of Hackensack University Medical Center/John Theurer Cancer Center. The...

  • Research Assistant

    5 days ago

    Nutley, United States Hackensack Meridian Health Full time

    Overview: The **Research Assistant - Cancer Prevention and Control Program - CPC** will be responsible for the day-to-day completion of tasks necessary for the success of an assigned behavioral science research project or set of related projects performed by or in conjunction with the Cancer Prevention and Control Program of Hackensack University Medical...

  • Scientific Director, Center for Discovery and Innovation

    5 days ago

    Nutley, New Jersey, United States Hackensack Meridian Health Full time

    Overview The Scientific Director-Center for Discovery and Innovationwill serve as the Deputy Chief Scientific Officer (CSO) of the HMH Center for Discovery and Innovation (CDI) as a senior management position reporting directly to the CSO and Chief Operating Officer of the CDI. This role will promote excellence in scholarship and research, assume adherence...

  • Senior Product Manager

    4 days ago

    Nutley, New Jersey, United States VIVOS Professional Services, LLC Full time

    Job Title: Senior Product Manager, Consumer Marketing, Alzheimer's DiseasePharmaceutical Experience (Neurology exp)Hybrid remote - 2 days on-site - 3 days remoteEast Coast onlyJob SummaryWe are seeking a Senior Product Manager of Consumer Marketing to join the US Alzheimer's Disease marketing team. This individual will have a passion for consumers and a...

  • Senior Product Manager

    1 week ago

    Nutley, United States VIVOS Professional Services, LLC Full time

    Job Title: Senior Product Manager, Consumer Marketing, Alzheimer’s DiseasePharmaceutical Experience (Neurology exp)Hybrid remote - 2 days on-site - 3 days remoteEast Coast onlyJob SummaryWe are seeking a Senior Product Manager of Consumer Marketing to join the US Alzheimer’s Disease marketing team. This individual will have a passion for consumers and a...

  • Senior Product Manager

    6 days ago

    Nutley, United States VIVOS Professional Services, LLC Full time

    Job Title: Senior Product Manager, Consumer Marketing, Alzheimer’s DiseasePharmaceutical Experience (Neurology exp)Hybrid remote - 2 days on-site - 3 days remoteEast Coast onlyJob SummaryWe are seeking a Senior Product Manager of Consumer Marketing to join the US Alzheimer’s Disease marketing team. This individual will have a passion for consumers and a...

  • Product marketing manager

    2 weeks ago

    Nutley, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionJob SummaryWe are seeking a Senior Product Manager of Consumer Marketing to join the US Alzheimer's Disease marketing team. This individual will have a passion for consumers and a proven ability to manage and execute integrated consumer promotional campaigns and patient support materials that help enable us to fulfill...

  • Veterinary Technician

    1 month ago

    Nutley, United States HMH HOSPITALS CORPORATION Full time

    The Veterinary Technician will provide care for research animals and general technical assistance to the veterinary staff and researchers at the Animal Facility at the Center for Discovery and Innovation, HMH. The Center for Discovery and Innovation- CDI was established by Hackensack Meridian Health (HMH) as an academic basic and translational research...

  • Veterinary Technician

    3 weeks ago

    Nutley, United States HMH HOSPITALS CORPORATION Full time

    The Veterinary Technician will provide care for research animals and general technical assistance to the veterinary staff and researchers at the Animal Facility at the Center for Discovery and Innovation, HMH. The Center for Discovery and Innovation- CDI was established by Hackensack Meridian Health (HMH) as an academic basic and translational research...

  • Senior Clinical Programmer Analyst

    4 weeks ago

    Nutley, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionQualifications• Minimum 10 years of relevant work experience to include data management and/or database programming and spec Design activities including 10 years in Medidata RAVE• Strong Programming skill set.• Knowledge of Python, building dashboards.• Knowledge of API programming.• Demonstrate excellent...

  • Senior Clinical Programmer Analyst

    3 weeks ago

    Nutley, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionQualifications• Minimum 10 years of relevant work experience to include data management and/or database programming and spec Design activities including 10 years in Medidata RAVE• Strong Programming skill set.• Knowledge of Python, building dashboards.• Knowledge of API programming.• Demonstrate excellent...

  • Senior Clinical Programmer Analyst

    3 weeks ago

    Nutley, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionQualifications• Minimum 10 years of relevant work experience to include data management and/or database programming and spec Design activities including 10 years in Medidata RAVE• Strong Programming skill set.• Knowledge of Python, building dashboards.• Knowledge of API programming.• Demonstrate excellent...