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Senior Director of Statistics

Company: Takeda Pharmaceutical
Location: East Orange
Posted on: November 24, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.Our Data Sciences Institute (DSI) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.As part of DSI, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence.To attract and retain the very best talent, we in Takeda SQS are open to flexible or remote working for some roles. Such roles will have a connection to a Takeda R&D center.How you will contribute:

  • Serve as leader, expert, mentor and manager of group supporting translational and exploratory statistical analyses in support of Takeda R&D assets across Therapeutic Area Units (TAUs)
  • Drive collaborations with biomarker, translational and clinical scientists across TAUs to enable biomarker development strategies for early clinical development decision making
  • Strategize and prioritize opportunities for Quantitative Sciences group AI/ML, RWE, advanced analytics and modeling to maximize impact on the organization
    • Lead implementation of strategies, goals, and priorities for the Quantitative Sciences group within the broader SQS organization
    • Oversee and ensure achievement of all deliverables and milestones for programs across TAUs
    • Align analytical efforts and resource allocation with TAU strategies, portfolio priorities, partner lines work, and with Digital and Technology
    • Manage, mentor and grow interdisciplinary team of biostatisticians, computational scientists and data scientists to integrate translational and early clinical assets to advance R&D programs
    • Promote statistical innovation and collaborations in data analytics for exploratory biomarker research representing Quantitative Sciences group
    • Develop and manage relationships with the external research community; serve as the scientific point person at meetings with KOLs, conferences, and industry events
    • Provide statistical leadership in the development and review of the study synopsis, protocol, statistical and exploratory analysis plans, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAUs as appropriate
    • Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across TAUs, including timelines
    • Identify and interact with external statistical experts for issues related to design, methodology and results as the primary contact and spokesperson
    • Increase efficiency of the Statistics function through development of standard and/or innovative analysis methodology, data presentations, and sharing of best practices
    • Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management
    • Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analyses techniques, and lead implementation of innovative approaches within and/or across TAUs as appropriate.
      • Demonstrate leadership of TAU, BU, or SQS function or specialty area in preclinical / clinical / translational
      • Act as a cross functional leader and accountable decision maker that has direct impact on R&D
      • Define and contribute to strategic vision, mission and respective implementation for the promotion of SQS within TAUs, BUs, and R&D functions
      • Identify opportunities and create delivery for DSI mission to make R&D business impact
      • Be involved in mentorship, matrix or direct management of large team of SQS colleagues
      • Be accountable for growth and development of SQS and DSI talent profile
      • Show influential leadership both within and outside of Takeda in area of expertiseMinimum Requirements/Qualifications:
        • Applicant for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences (e.g., Applied Mathematics, Physics, Engineering or related quantitative field) along with the following specific credentials: PhD with -12+ years experience or MS with -15 years experience
        • Provide strategic leadership
          • Mobilize high performance from teams
          • Influence beyond SQS and DSI
          • Knowledge of the pharmaceutical drug discovery and development process with a relevant track record of R&D hands-on work and leadership
          • Experience in the early clinical stages of drug development.
          • Expertise and track record of implementation of advanced statistical modeling across several TAUs
          • Expertise in biomarker and outcomes instrument validation for clinical trial endpoint use
          • Pragmatic leader with a focus on driving the teams using fit-for-purpose philosophy and a track record of creativity and innovation
          • Track record of integrating discovery/medical and statistical best practices into translational and clinical research to improve reproducibility, efficacy, safety of the exploratory endpoints across phases of drug development
          • Demonstrated ability to work collaboratively with research project teams in both preclinical and clinical development programs
          • Ability to translate/explain complex statistical concepts to non-experts; ability to speak across disciplines of Quantitative Sciences umbrella: statistics, engineering, applied mathematics, computational biology, pharmacokinetic/pharmacodynamic modeling, and others
          • Excellent communication and presentation skills
          • Expertise in statistical programming, modeling and simulations
          • Technical expertise across a TAU - understands the TAU strategy to lead and drive optimized methodology in drug R&D
          • Leadership in TAU and functional methodology decision making to optimize the likelihood of drug R&D success
          • Solid technical background in statistical and signal processing methods of analysis for imaging, physiological, sensor data
          • Capability to create technical strategic vision and implement long-term innovation that is aligned with global regulatory and payer policies and trends
          • Capability to create major technical and methodology projects and guide them to implementation across R&D
          • The ability to establish external network to facilitate collaborations across industry, government, and academia
          • Strong track record of scientific publications, both methodological developments as well as applied
          • Track record of technical proficiency in hands data analysis and scientific programming using variety of languages such as SAS, R, MATLAB, python, Julia, C/C++What Takeda can offer you:
            • Comprehensive Healthcare: Medical, Dental, and Vision
            • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
            • Health & Wellness programs including onsite flu shots and health screenings
            • Generous time off for vacation and the option to purchase additional vacation days
            • Community Outreach Programs and company match of charitable contributions
            • Family Planning Support
            • Flexible Work Paths
            • Tuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $194,000 to $278,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, East Orange , Senior Director of Statistics, Executive , East Orange, New Jersey

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