Executive Director, Biostatistics

1 month ago

New York, New York, United States Daiichi Sankyo Full time
Executive Director, Biostatistics in Basking Ridge at Daiichi Sankyo

Join a Legacy of Innovation 110 Years and Counting

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world–class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

Reviews and provides strategic input to the entire portfolio or specific therapeutic areas from Phase 1 through life cycle management. Provides oversight of statistical activities performed by direct reports or staff of the global function to support drug development and life cycle management. Represents the function in global regulatory/heath authorities' meetings. High–level negotiation and oversight of CROs and provides oversight of CRO/sponsor partnership. Sets the vision and strategy for the function. Accountable for the management, performance, and development, both technical and career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.

Responsibilities:

Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities performed by direct reports and biostatisticians across the regional/global function, when assigned. Develops, directs, prioritizes and monitors all assigned projects and processes relevant to project development plan, study design, statistical analysis, data display, results validation, interpretation and reporting to accelerate worldwide product submissions and approvals.Drug Development Strategy: Reviews and provides strategic input to entire portfolio or specific therapeutic areas from Phase I through life cycle management. Briefs senior management on assigned projects or studies as needed. Subject matter expert in multiple therapeutic areas.CRO / Vendor Oversight: Manages higher–level negotiation and provides oversight of budget, resources and timelines with contract research organizations (CROs) for multiple projects across the department and ensures timely delivery of high quality deliverables at reasonable cost. Develops overall outsourcing strategy for the function and provides oversight of the CRO/sponsor partnership.Global Health Authority Interaction / Negotiation: Provide strategic input for global submission, global health authority interaction and negotiation. Reviews documents and responses submitted to health authorities globally. Represents the function at health authority meetings.Global BDO Strategy to Improve Drug Development: Sets the vision and strategy for the function; Identifies areas to be improved and initiates rectification or remedial activities; Develops the strategy for technology to improve the overall efficiency in bringing products to market. Authors or initiates writing of global standard operating procedures; Monitors and enforces compliance of standard procedures and processes.People Management: Has administrative responsibilities for recruiting, retaining, developing, and managing employees. Identifies training needs of staff, not limited to direct reports, and implement the trainings. Leverages manpower and talents across Regions to maximize efficiency. Mentors or acts as functional manager of staff resides in other offices as needed.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)PhD in statistics or biostatistics preferred Experience Qualifications10 or More Years relevant experience in the pharmaceutical industry, including new drug application submission experience or equivalent. preferred7 or More Years experience in direct management of statistical group preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

  • Head of Biostatistics

    7 hours ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsCompensation and Benefits:20 Days of Paid Time Off (PTO)1 Week allocated for mental health or sick leave1 Week for Christmas-New Year’s holiday (company closure)Competitive Base Salary with Performance-Based BonusesComprehensive Medical Coverage fully paid for the employee401K Retirement PlanOpportunities for Professional...

  • Head of Biostatistics

    5 days ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits Overview:20 Days of Paid Time Off (PTO)1 Week allocated for mental health/sick leave1 Week holiday break during Christmas-New Year (company closure)Competitive Base Salary plus Performance-Based BonusesComprehensive Medical Coverage fully paid for the employee401K Retirement PlanOpportunities for Development &...

  • Head of Biostatistics

    13 hours ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsCompensation and Benefits:20 Days of Paid Time Off (PTO)1 Week allocated for mental health/sick leave1 Week: Holiday closure during Christmas-New YearCompetitive Base Salary plus Performance-based BonusesComprehensive Medical Coverage fully paid for the employeeRetirement Savings Plan (401K)Opportunities for Professional...

  • Head of Biostatistics

    6 days ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits:20 Days Paid Time Off1 Week of Mental Health/Sick Leave1 Week: Holiday Closure (Christmas to New Year)Competitive Base Salary + Performance-Based BonusComprehensive Medical Coverage Fully Paid for Employee401K Retirement PlanOpportunities for Professional Development and TrainingFlexible Hybrid Work...

  • Head of Biostatistics

    7 hours ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits:20 Days of Paid Time Off (PTO)1 Week allocated for mental health/sick leave1 Week: Holiday break during Christmas-New Year (company closure)Competitive Base Salary plus Performance-based BonusesComprehensive Medical Coverage fully paid for the employee401K Retirement PlanOpportunities for Development & Training to...

  • Head of Biostatistics

    6 days ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsCompensation and Benefits:20 Days of Paid Time Off (PTO)1 Week designated for mental health/sick leave1 Week: Holiday Closure during the Christmas-New Year periodCompetitive Base Salary complemented by a Performance-Based BonusComprehensive Medical Coverage fully paid for the employee401K Retirement PlanOpportunities for...

  • Head of Biostatistics

    15 hours ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits Overview:20 Days of Paid Time Off (PTO)1 Week allocated for mental health/sick leave1 Week for the Christmas-New Year holiday (company closure)Competitive Base Salary with Performance-based BonusesComprehensive Medical Coverage fully paid for the employee401K Retirement PlanOpportunities for Development & Training...

  • Head of Biostatistics

    2 days ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits:20 Days Paid Time Off1 Week of mental health/sick leave1 Week: Holiday Closure (Christmas to New Year)Competitive Salary with Performance-Based BonusesComprehensive Medical Coverage for employees401K Retirement PlanOpportunities for Professional DevelopmentFlexible Work ArrangementsPet-Friendly WorkplaceKey...

  • Head of Biostatistics

    15 hours ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits Overview:20 Days of Paid Time Off (PTO)1 Week allocated for mental health/sick leave1 Week: Holiday Closure during the Christmas-New Year periodCompensation: Base Salary plus Performance-Based BonusesComprehensive Medical Coverage: 100% paid for employeesRetirement Savings: 401K PlanProfessional Development:...

  • Head of Biostatistical Analysis

    8 hours ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits:20 Days Paid Time Off1 Week of Mental Health/Sick Leave1 Week: Holiday Closure (Company Shutdown during Christmas-New Year)Competitive Base Salary + Performance-Based BonusComprehensive Medical Coverage Fully Paid for Employee401K Retirement PlanProfessional Development & Training OpportunitiesFlexible and Hybrid...

  • Head of Biostatistics

    12 hours ago

    New York, New York, United States nitruc Full time

    Position: Director of BiostatisticsBenefits Overview:20 Days of Paid Time Off (PTO)1 Week designated for mental health and sick leave1 Week holiday closure during Christmas to New Year'sCompetitive Base Salary complemented by Performance-based BonusesComprehensive Medical Coverage fully funded for the employee401K Retirement PlanOpportunities for...

  • Associate Director, Biostatistics

    1 month ago

    New York, New York, United States Pfizer Full time

    JOB SUMMARYThe A ssociate Director, Oncology Biometrics is a skilled biostatistician who can work independently as the study statistician for Phase 1-2 studies and under the direction of a Director of Biostatistics, or above, as the study statistician for Phase 3 studies. The person in this role: Is an individual contributor role who specializes in creating...

  • Senior Biostatistical Scientist

    6 days ago

    New York, New York, United States Luminary Group Full time

    Job OverviewLuminary Group is on the lookout for a talented and experienced Senior Biostatistical Scientist to join our esteemed client. In this pivotal role, you will provide essential statistical guidance and expertise for various research initiatives and clinical trials. Your collaboration with multidisciplinary teams will be vital in analyzing,...

  • Executive Director

    2 days ago

    New York, New York, United States Ag 1 Source Full time

    Executive Director OpportunityAg 1 Source is seeking an experienced Executive Director to lead their specialized feed ingredients and commodities organization. This role involves managing the existing business platform and creating opportunities for growth beyond the Board of Directors' expectations. We are seeking creative business minds in the Livestock,...

  • Executive Director of Development

    12 hours ago

    New York, New York, United States New York Common Pantry Full time

    About the RoleNew York Common Pantry is seeking a seasoned and strategic Chief Development Officer to lead the growth of its fundraising program. The successful candidate will design and implement a comprehensive fundraising strategy to expand and diversify philanthropic income sources, with a focus on building a robust major and annual giving program.Key...

  • Executive Director of Development and Strategy

    8 hours ago

    New York, New York, United States New York Common Pantry Full time

    About the RoleNew York Common Pantry is seeking a seasoned and strategic Chief Development Officer to lead the growth of its fundraising program. The successful candidate will design and implement a comprehensive fundraising strategy to expand and diversify philanthropic income sources, with a focus on building a robust major and annual giving program.Key...

  • Executive Director of Operations

    14 hours ago

    New York, New York, United States Novaris Search Full time

    Job Title: Executive Director of OperationsAbout Novaris Search: Novaris Search is a leading provider of executive search services, specializing in placing top talent in the healthcare industry.Job Summary: We are seeking an experienced Executive Director of Operations to join our client, a growth-minded Autism Healthcare provider that specializes in Applied...

  • Executive Creative Director

    3 days ago

    New York, New York, United States Heartbeat Full time

    About HeartbeatAt Heartbeat, we are a leading healthcare marketing & creative agency based in the heart of the city. We are passionate about empowering Challenger Brands, fostering a diverse and inclusive community, and creating an exceptional work environment. As part of our team, you will have the opportunity to work on exciting projects, collaborate with...

  • Executive Director of Operations

    14 hours ago

    New York, New York, United States Novaris Search Full time

    Job Title: Director of OperationsAbout Novaris Search: Novaris Search is a leading provider of executive search services, specializing in placing top talent in the healthcare industry.Job Summary: We are seeking an experienced Director of Operations to join our client, a growth-minded Autism Healthcare provider that specializes in Applied Behavior Analysis...

  • Executive Director, Content Development

    4 weeks ago

    New York, New York, United States Dow Jones Full time

    Job Description:ABOUT OUR ORGANIZATIONDow Jones is a global provider of news and business information, delivering content to consumers and organizations around the world across multiple formats, including print, digital, mobile, and live events.Dow Jones has produced unrivaled quality content for more than 125 years and today has one of the world's largest...