29 days old

Senior Director, Therapeutic Area Programming Lead and Operations

USA - 2778 Millennium Pharma, Inc.
Boston, MA 02109
  • Job Code
    R0019131

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Job Description

  • Leads the development and implementation of operational best practices in the areas of programming deliverables, utilization of data standards, and vendor strategies/oversight. Works in close collaboration with the SQS Head of Operations, the Head of Clinical Data Solutions, and Head of Programming Innovations to ensure alignment across relevant stakeholders and data analysis processes.
  • Leads statistical programming activities across all assets within a Therapeutic Area Unit (TAU) to ensure timely and accurate design and execution of statistical analysis deliverables; implement the global functional strategy related to innovation in resourcing, technologies and automation, processes and standards to maximize efficiency and quality.
  • Requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process. The incumbent will manage internal and external (Functional Service Providers) programmers, in addition to overseeing work outsourced to primary CRO partners. The scope of work covered across internal and external resources includes study level programming (analysis datasets, Tables, Listings, Figures, etc.), integrated and pooled analyses, preparation of data and documentation for electronic submissions, ad hoc analyses, and other regulatory commitments and publication support.
  • Serves as a key member of Programming department leadership team and the SQS extended management team.

  • Operations:
    • Drive the development, and lead the implementation, of best practices, programming guidelines and specifications, and documentation tools, that can be seamlessly applied regardless of operating/outsourcing model.
    • Attend relevant Takeda Trial Delivery Operating Model governance meetings and serve as a key leader in our partner relationships.
    • Drive the strategic and tactical CRO and FSP relationships for programming to create optimized operational interfaces for cost, quality and timely delivery.
    • Drive the enterprise oversight of the portfolio for programming delivery by partnering with the Head of SQS Operations to effectively track and monitoring metrics in effort to identify and mitigate risks.
    • Collaborate with the Head of Clinical Data Solutions and Data Standards to ensure our data standards are fit for purpose and effectively communicated and utilized internally and externally.
    • Support the implementation of tools and technologies developed by the Programming Innovations team to ensure proper training and understanding by end users.
  • Therapeutic Area Programming Lead:
    • Lead by setting strategies, goals, and priorities aligned with both SQS and TAU business needs and strategies.
    • Oversee all programming activities conducted by internal staff, external contractors (FSP), and CROs including:
  • Definition and generation of analysis datasets and TLFs for clinical studies and electronic submissions.
  • Data requirements and documentation for electronic submissions
  • Management of project timelines related to statistical programming deliverables
  • Ad hoc analyses, other Regulatory commitments, and publications
  • Provide access to internal and external programming expertise and capacity to support R&D
  • Provide input for planning and management of resources and external budgets related to statistical deliverables. Plan and manage internal administrative budget for the Programming function.
  • Ensure that appropriate training and education programs are in place to develop personnel to help achieve functional goals and long-term strategy.
  • Represent function in external professional initiatives and organizations such as SUGI, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
  • Ensure compliance of the programming function with Takeda SOPs, standards and all applicable regulations.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2020-04-28 Expires: 2020-05-27
Sponsored by:
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Sponsored by:
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Senior Director, Therapeutic Area Programming Lead and Operations

USA - 2778 Millennium Pharma, Inc.
Boston, MA 02109

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