Director, Biostatistics and Data Science

1 day ago


Jersey City New Jersey, United States Mitsubishi Tanabe Pharma Full time
About the Role

Mitsubishi Tanabe Pharma America is seeking a highly skilled and experienced Director, Biostatistics to join our team. As a key member of our organization, you will be responsible for managing biostatistics activities and developing tools, technologies, and technical solutions leveraging data science, advanced analytics, machine learning, and other algorithms to support clinical development activities.

Key Responsibilities
  • Manage statistical planning and execution of multiple clinical trials
  • Provide expertise in clinical trial design, SAP, and trial-related documents
  • Develop and execute biostatistics, statistical programming, and data management strategies to support clinical development activities
  • Provide statistical leadership in ongoing clinical trial programs and development of new programs
  • Ensure quality and timeliness of statistical, programming, and data management deliverables
  • Support interactions with global health authorities and partner contract research organizations
  • Accountable for accuracy of statistical analyses and proposals in materials for health authority meetings
  • Provide resources and support analytical activities for scientific publications
  • Closely collaborate with members of the Statistical Programming, Data Management, and Medical Writing organizations
  • Establish and ensure adherence to biostatistics and statistical programming best practices, SOPs, standards, and processes
  • Collaborate with and oversee work of external service providers or suppliers involved in the drug development process
Requirements
  • Master's degree in Biostatistics/Statistics required
  • Doctoral degree in Biostatistics/Statistics preferred
  • 10+ years in biotech/pharmaceutical industry in roles of increasing biostatistics responsibilities
  • Experience with multiple (s)NDAs, BLAs, MAAs required
  • J-NDA experience is a plus
  • Ideal candidate has worked in multiple therapeutic areas and has experience with innovative Phase II clinical study designs for rare/uncommon disorders encompassing small molecules, large molecules, and biologics
  • Demonstrated record of fostering creativity, productivity, execution with urgency, teamwork, and accountability
  • Team-builder who leads by example and encourages collaboration across departments to achieve objectives
  • Comfort with model-based and agile drug development important
  • Appreciation for observational methodologies preferred
  • Ability to articulate complex methodologies to senior executives
  • Up to 20% domestic and international travel required
Our Value Proposition

Mitsubishi Tanabe Pharma America offers a unique opportunity to work in a fast-paced, entrepreneurial environment with a global pharmaceutical company. We provide a competitive benefits package, including medical and dental health benefits, short-term and long-term disability plans, company-paid and supplemental life insurance, and additional voluntary benefits. Our generous PTO policy is based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $160,000 - $235,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment, if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program and Long-Term Incentive (LTI) program. Specific information about the plans, including eligibility rules and target, will be furnished upon hire.



  • Jersey City, New Jersey, United States Mitsubishi Tanabe Pharma Full time

    About Mitsubishi Tanabe Pharma AmericaMitsubishi Tanabe Pharma America is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation, a research-driven pharmaceutical company with a storied reputation spanning over 300 years. Our parent company has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis,...


  • Redwood City, California, United States Corcept Therapeutics Full time

    Job SummaryWe are seeking a highly skilled Associate Director, Biostatistics to join our team at Corcept Therapeutics. This is a critical role that will lead the execution of statistical components of our development programs.Key ResponsibilitiesCollaboration and LeadershipPartner with cross-functional teams, including Clinical Development, Regulatory,...


  • Redwood City, California, United States Meet Full time

    About MeetMeet is a global pharmaceutical company dedicated to creating innovative therapies to improve healthcare standards and address unmet medical needs worldwide. With over 100 years of scientific expertise and a presence in over 20 countries, our teams leverage cutting-edge science and technology to develop novel treatments in oncology and other...


  • Foster City, California, United States Gilead Sciences, Inc. Full time

    Associate Director, Biostatistics - InflammationUnited States - New Jersey - Toms RiverGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living...


  • New York City, United States Eikon Therapeutics Full time

    Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...


  • New York City, United States Eikon Therapeutics Full time

    Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...


  • Foster City, California, United States Gilead Sciences, Inc. Full time

    Sr. Director, BiostatisticsUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with...


  • New York, New York, United States Memorial Sloan Kettering Full time

    Job SummaryWe are seeking a highly motivated and skilled Postdoctoral Fellow in Biostatistics to join our interdisciplinary microbiome research program at Memorial Sloan Kettering Cancer Center. The successful candidate will work on developing innovative statistical methods, scalable computational algorithms, and accessible software packages for our unique...


  • Jersey City, New Jersey, United States Tiger Analytics Full time

    About Tiger AnalyticsTiger Analytics is a leading advanced analytics consulting firm that helps Fortune 100 companies unlock business value from data. Our team of experts brings deep expertise in Data Science, Machine Learning, and AI to drive business growth and innovation.Job SummaryWe are seeking a highly skilled Data Science Consultant/Manager to join...

  • Head of Biostatistics

    2 weeks 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

    2 weeks 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

    2 weeks ago


    Foster City, California, United States Gilead Sciences, Inc. Full time

    Senior Director of Biostatistical OperationsAt Gilead Sciences, we are dedicated to fostering a healthier world for everyone. For over 35 years, we have addressed significant health challenges, including HIV, viral hepatitis, COVID-19, and cancer. Our relentless pursuit of innovative therapies aims to enhance lives and ensure global access to these vital...

  • Head of Biostatistics

    2 weeks 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

    2 weeks 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

    2 weeks 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

    2 weeks 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

    2 weeks 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...

  • Head of Biostatistics

    2 weeks 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...


  • Foster City, California, United States Gilead Sciences, Inc. Full time

    Associate Director, BiostatisticsUnited States - New Jersey - ParsippanyGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with...

  • Head of Biostatistics

    2 weeks 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:...