Statistical and Data Science Innovative Methods Lead

Company: Takeda Pharmaceutical
Location: Boston
Posted on: January 16, 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 DescriptionTakeda 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.The objectives and overall purpose of this role include:

• Advance the consistent use of innovative statistical and data science methods across all stages of R&D, and across all SQS TAUs/BUs and functions.
• Collaborate with and drive virtual team members embedded within the SQS TAUs/BUs and functions to build and deliver SQS institutional knowledge.
• Provide technical leadership and guidance for selected projects by consulting on clinical development and regulatory strategy.
• Establish strong network and collaborations with internal and external statistical experts to bring new ideas to increase drug development efficiency.
• Enhance Takeda's reputation in the Statistical, Quantitative and Data Sciences internal to Takeda and across the broader health care community.Delivery & Business AccountabilitiesOrganize and drive the overall SQS strategy to develop institutional knowledge across SQS TAUs/BUs and functions to maximize the use of consistent and innovative statistical and data science methods.
  • Promote statistical and data science methodological and software development that is driven by project needs.
  • Coordinate multiple SQS Research Hubs of team members embedded within SQS TAUs/BUs and functions, to drive innovative methods development through research, documentation, and education.
  • Provide strategic vision for long-term delivery innovation.
  • Provide statistical leadership and support to selected programs by consulting on study design, endpoints, analysis, interpretation, statistical regulatory strategy, regulatory
    responses, and regulatory interactions.
  • Establish strong network and collaborations with internal and external statistical experts to support development activities and bring new ideas to increase drug development
    efficiency.
  • Actively participate in external professional initiatives and organizations to identify industry best practice and its applicability in Takeda.
  • Enhance Takeda's reputation in statistical societies and broaden networks with regulatory, academic and pharmaceutical industry statisticians.CORE ELEMENTS RELATED TO THIS ROLEExperience representing Statistics function in interactions with regulatory agencies.
    • 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.
      • Excellent oral and written communications skills.
      • Specialized statistical expertise in multiple therapeutic areas and development phases.
        • Strong interpersonal and people management skills.
        • Strong project management skills.
          • Strong collaborative skills and ability to work with a cross-functional team.
          • Ability to influence, inspire and motivate others, without direct hierarchical authority, and affect change across organizational boundaries.Technical/Functional (Line) Expertise
            • Technical expertise across multiple TAUs with ability to drive optimized methodology in drug R&D.
            • Leadership in functional methodology decision making to optimize the likelihood of drug R&D success across multiple TAUs/BUs.
            • Capability to create technical strategic vision and implements long-term innovation that is aligned with global regulatory and payer policies and trends.
            • Capability to create major technical and methodology projects and guides them to implementation across R&D.
            • The ability to establish external network to facilitate collaborations across industry, government, and academia.EDUCATION:Applicant for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials:
              • PhD with -12+ years experience
              • MS with -15 years experienceBEHAVIOURAL COMPETENCIESAn ideal candidate for this position should:
                • Provide strategic leadership
                • Mobilize high performance from teams
                • Influence beyond SQS and DSIAbsent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.This job posting excludes CO applicants.
                  • 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 ProgramsDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.ADDITIONAL INFORMATIONTakeda 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.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

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