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Senior Manager, Statistics

Company: Takeda Pharmaceutical
Location: Elizabeth
Posted on: May 9, 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 in our Cambridge, MA office.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: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.POSITION ACCOUNTABILITIES:

  • Lead project delivery directly related to global project teams or other functions
  • Work independently and prioritize delivery for projects cross functionally and with vendors
  • Effectively drive and influence project teams towards seamless delivery while enabling and making decisions
  • Contribute to asset level strategies to identify and mitigate delivery risks
  • Have internal and external presence on delivery risks and enabling risk mitigation actions
  • Have the ability to implement process and best practice changes through effective delivery risks -CORE ELEMENTS RELATED TO THIS ROLE:
    • Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
    • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
    • Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
    • Strong statistical programming skills
    • Excellent oral and written communications skills.
    • Specialized statistical expertise in multiple therapeutic areas or development phases.
    • Strong project management skills.
    • Strong collaborative skills and ability to work with a cross-functional team.
    • Independently represent Data Science function on projects leading data strategies related to diseases, assets or other areas of interest in Takeda's ecosystem.
    • Play a leadership role in the development and review of data science projects and their respective strategies, spanning spontaneous data exploration in individual data sources to designed and planned studies requiring the synthesis of many data archetypes.
    • Perform beginning-to-end data analyses, from data strategy to objective formulation, to data exploration and insights, to hypotheses formulation, experimental design, writing analysis plans, data cleaning and curation, executing analysis, to interpretation and preparing reports with documentation.
    • Develop and support optimal data handling and data provenance practices utilizing reproducible, interpretable data research approaches
    • Strengthen Takeda's advanced analytics toolkit by identifying and applying emerging innovative techniques, as well as by advancing the state of the art and developing novel analysis tools as needed.
    • Collaborate effectively within a matrix environment with business leaders and scientists to identify and develop appropriate goals for data science work (for example identifying sensitive and specific endpoints for segmenting patient population, tracking disease progression, quantifying quality of life, etc.). Partner with colleagues from a multitude of functions that span R&D (e.g., pharmacology, chemistry, imaging, translational sciences, computational biology, experimental medicine) to Commercial (patient services, sales and marketing, medical information).
    • Provide thought leadership in concepts related to data acquisition and ingestion working with Data Architecture and IT. - Understand respective systems security and provide support for data transparency, disclosure, and governance. - Strategically connect with Takeda enterprise projects related to the Digital Advisory Board and the Global Data Council.
    • Work closely with Takeda statisticians and other quantitative experts to ensure statistical issues in data analysis are addressed as needed.
    • Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the program. - Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
    • Increase the internal impact of Takeda's data science work by identifying opportunities across therapeutic or disease areas and business units.
    • Increase the external recognition of Takeda's data science work by participating in conferences, publishing work and developing external collaborations
    • Serve as global statistical lead for biomarker development in Oncology TA.
    • Play a leadership role in development and completion of major statistics deliverables and milestones in collaboration with other functions.
    • 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 statistical leadership and support for internal decision making, regulatory meetings, submissions and follow up.
    • 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.
    • Participate/Leads in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and its applicability in TakedaDIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise
      • The capability to gain broader technical expertise outside of primary area -
      • The ability to communicate effectively with cross functional teams and explain statistical and quantitative concepts to non-experts
      • The drive for learning techniques and methods and also for continuous improvement through various avenues of the organizationLeadership -
        • Lead projects directly or indirectly related to Global ProJet Teams (GPTs) or other functions
        • Work independently and prioritize projects
        • Effectively drive and influence project teams towards objectives while enabling and making decisions
        • Contribute to asset level strategies
        • Have internal and external prescience on topics of interestEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
          • PhD with -3+ years experience in statistical - or quantitative field
          • MS with -6+ years experience.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.#LI-SGM -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, Elizabeth , Senior Manager, Statistics, Executive , Elizabeth, New Jersey

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