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Senior Manager, Programming

Company: Takeda Pharmaceutical
Location: Newark
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 Description -Takeda SQS is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. - 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.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. - - - -ACCOUNTABILITIES -

  • Contributes to shape the technical direction of automating statistical programming deliverables and process improvements by supporting technological innovation and creativity within Takeda SQS. -
  • Leads development, implementation and release of global SAS macros & automation tools for key statistical programming activities such as TLFs, submission datasets (SDTM & ADaM) creation; and related derivations. -
  • Ensure that software development lifecycle is followed for standards development and appropriate documentation is created and maintained to support GCP compliance.
  • Provides subject matter expertise on standard domains across all therapeutic areas as needed.
  • Contributes to and/or leads process improvement initiatives.
  • Participate in Data Standards and/or ADaM and/or TLF Governance Board(s) by representing Programming Standards and contribute to review and optimization of corporate standards.
  • Collaborate with cross functional teams to create SOPs, Work Instructions and guideline documents on standard tools, processes and methodologies as needed.
  • Accountable to manage multiple projects across diverse platforms. Proficiency in other software programming languages such as R, Python, Java etc. is an added advantage. - - -CORE ELEMENTS RELATED TO THIS ROLE
    • Provides programming leadership and support to clinical study teams, including deployment of programming strategies, standard specifications and templates to comply with regulatory requirements, SOPs and work practices. -
    • Demonstrates advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations. -
    • Combines strong general knowledge of technical and programming methods with applied experience to complete tasks and mentor more junior staff. -
    • Effectively drives and influences project teams towards objectives while enabling and making decisions. -
    • Leads non-project initiatives across statistical programming. - - -DIMENSIONS AND ASPECTS - -Technical/Functional (Line) Expertise
      • Comprehensive understanding of the pharmaceutical industry and statistical programming (e.g., clinical development, the prescription drug distribution process, etc) -
      • Excellent analytical, technical, and computer skills -
      • Expert level SAS programming ability and experience with other analytical tools, e.g. R, Python. -
      • Advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations - -Leadership -
        • -Demonstrated ability to work and influence across functions, regions and cultures -
        • Excellent communicator, able to convey both complex ideas and data, verbally and in writing -
        • Proven skills as an effective team player who can engender credibility and confidence within the company -
        • Ability to distill complex technical programming ideas in simple comprehensible terms in order to influence decisions and outcomes -
        • Embraces and demonstrates a diversity and inclusion mindset -
        • Leads projects directly or indirectly related to GPTs or other functions -
        • Independently works and prioritizes projects -
        • Effectively drives and influences project teams towards objectives while enabling and making decisions -
        • Contributes to asset level strategies -
        • Has internal and external presence on topics of interest - - -Decision-making and Autonomy -
          • Recommends strategic decisions that impact the statistical programming function -
          • Accountable for statistical programming decision making within study level - -
          • Participates in initiatives that seek diverse input from multiple constituents and stakeholders to drive innovative solutions - -Interaction
            • Effectively understands the changing external and internal environment - -
            • Able to effectively implement R&D's partnership strategy as it applies to statistical programming -
            • Builds strong relationships and collaborates effectively with other interfacing Takeda functions, including but not limited to statistics, data management, clinical operations, medical directors -Innovation
              • Comfortable challenging the status quo and proposing forward thinking innovative solutions -
              • Implements new ways of working utilizing a wide variety of software (e.g. SAS, R, Python) -
              • Proposes and embeds ideas around innovative solutions, and leverages new ways to accelerate existing milestones -Complexity
                • Able to work in a global ecosystem (internal and external) with a high degree of complexity -
                • Possesses requisite deep expertise of statistical programming and computing environments - - -
                • Able to see and understand broader, enterprise level perspective and impact to statistical programming -
                • Exhibits awareness and relevance of best practices related to data sharing - -
                • Provides input regarding standardization and programming of novel data types (including real world evidence, personalized medicine, and wearable devices) as part of a larger digital strategy -EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
                  • MS with -6+ years of industry related experience. - -
                  • BS with -8+ years of industry related experience. -
                  • Comprehensive knowledge of technical and regulatory requirements with CDISC submission experience. -
                  • Experience leading business process transformations and organizational culture change as well as contributing to programming expertise on programs with complex business deliverables. -
                  • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development. -
                  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry. -ADDITIONAL INFORMATION
                    • 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; it can also be on-site in Cambridge, MA. -Empowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.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, Newark , Senior Manager, Programming, Executive , Newark, New Jersey

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