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Senior Manager, Statistics

Company: Takeda Pharmaceutical
Location: Ipswich
Posted on: May 13, 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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Statistics.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.POSITION OBJECTIVES:

  • Drives all statistical aspects of biomarker development for Takeda R&D assets for Oncology Cell Therapy Therapeutic Area Unit (OCTAU) covering design and analysis from pre-clinical to early clinical studies.
  • Drives data driven decision making in multidisciplinary team environment (comprising of preclinical, biomarker, translational and clinical scientists, and computational biologists and quantitative pharmacologists) by providing high level of statistical rigor to the analyses and interpretation of complex data generated by translational teams
  • Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up.
  • Establishes and drives OCTAU programs functional strategy for resourcing, processes and standards to maximize efficiency and global data integrability.
  • Participates in functional and cross functional initiatives including process and quality improvements.POSITION ACCOUNTABILITIES:
    • Serve as global statistical lead for biomarker development in OCTAU. Provide statistical leadership and support for internal decision making, regulatory meetings, submissions and follow up.
    • Review key program documents and presentations (portfolio entry document, PRC narratives, biomarker strategy plan), attend Translational Research meetings to develop a comprehensive overview of the existing data in pre-clinical and translational studies, form a deep understanding of the development rationale and strategy and the key questions that need to be answered from biomarker data, and help the teams identify any statistical shortfalls and propose solutions to overcome them
    • Attend scientific conferences (AACR, ASCO, SITC) and stay abreast with the latest developments in IO and cell therapy space with an eye towards acquiring biomarker data that can help augment internal data
    • Play a leadership role in development of Exploratory Analysis Plans and completion of major statistics deliverables and milestones in collaboration with other functions
    • Stay up-to-date on emerging technologies and associated data analytic techniques, external databases and novel methodologies that can help Takeda derive the maximum value out of the biomarker data.
    • Drive/participate in development and implementation of global systems, processes and standards to maximize quality and efficiency.
    • Leverage standardized analysis methods and reporting standards to maximize global data integrability; identifies best practice for utilization across programs. -
    • Provide or identify internal and external statistical expertise and capacity to support development activities. Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality. Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level. Provide input for planning and management of external budgets related to statistical deliverables.
    • Active participation in external professional initiatives and organizations to identify industry best practice and its applicability in Takeda.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
      • PhD in statistics/biostatistics or in other equivalent quantitative sciences with an emphasis on statistics with -3 years of relevant industry experience or MS in statistics with -6 years of relevant industry experience
      • Team work is key for this role. Candidate will be expected to routinely interface with other quantitative functions in industry and must have strong inter-personal, communication, and people management skills, and ability to influence others, without direct hierarchical authority, to affect change across organizational boundaries.
      • Expert knowledge across broad areas of statistical methodologies including subgroup analysis, longitudinal data analysis, multivariate methods, predictive modeling, machine learning, Bayesian modeling. Strong background in statistical modeling in R or SAS with the ability to independently code relevant programs.
      • Expert knowledge of statistical approaches for assays, and biomarker development and validation.
      • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
      • Excellent oral and written communications skills.
      • Strong project management skills.
      • Knowledge of IO Biology and experience working with raw data from emerging biomarker technology platforms in the space (CyToF, TCRSeq, Multiplexed IHC) is a plus -WHAT TAKEDA CAN OFFER YOU:
        • 401(k) with company match and Annual Retirement Contribution Plan
        • Tuition reimbursement Company match of charitable contributions
        • 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.In accordance with the CO Equal Pay Act, -Colorado Applicants Are Not Permitted to Apply.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.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, Lynn , Senior Manager, Statistics, Executive , Ipswich, Massachusetts

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