Director, Biostatistics Data Asset Governance Lead

il y a 1 semaine


Wavre, Wallonie, Belgique GSK Temps plein

Site Name:
UK - Hertfordshire - Stevenage, Belgium-Wavre, India - Karnataka - Bengaluru, India - Maharashtra - Worli Mumbai, Netherlands - Amsterdam, UK - Greater London, USA - Pennsylvania - Upper Providence

Posted Date:
Jan

Are you a leader with a broad and deep understanding of the data requirements and complexities of a Biostatistics (or equivalent) & Development organization? Are you a strategic thinker? Can you drive a step change in the way we manage and use our reported clinical data assets within GSK's Biostatistics group and beyond?


We are excited to announce that GSK's Clinical Programming department has established a new Data Asset Framework & Services Team.

The purpose of the Team is to provide a centralized function that manages and supports access to our data assets in a way that enables us to answer important scientific questions so that we can design efficient trials, understand our opportunities, and automate our processes.

We have been addressing this in individual delivery teams and projects.

Standards and technology have matured to enable this more holistically and thus the time is right to centralize the framework and services for our Data Assets.


We are looking for an exceptional person that is uniquely placed to implement a vision and strategy of a fit-for-purpose value-driven data governance framework for completed clinical trial data enabling easy and appropriate data re-use in close collaboration with Disease Area Heads in R&D, their teams and other partners with a focus on measuring and improving data quality, the protection of data and the implementation of clear data governance roles and responsibilities for ownership and stewardship of data assets, enabling consistent provisioning of fit-for-purpose data that are easy for R&D teams to use and R&D teams have clarity which processes to use with the ease of mind that data governance with transparent data ownership are embedded.

The distinct behaviour demonstrated by the Biostats Data Governance Lead is defined by Data Governance Thought Leadership, Innovation, Strategy Development and Delivery, and People Management & Development, this leader is accountable for designing the data governance for completed clinical trial data framework with a focus on improving data quality, the protection of data aided by transparent data governance roles and responsibilities for ownership and stewardship of data assets by
- partnering strongly with enterprise-wide data governance, risk management, data policy and legal groups
- providing the business leadership with regards to fit-for-purpose and value-adding data governance for completed clinical trial data
- partnering strongly with the Disease Area Heads in R&D and their teams to oversee the end-to-end data lifecycle management in accordance with applicable retention/preservation requirements for completed clinical trial data (internal or external) enabling them to deliver their asset-level Data strategy and modelling plans
- partnering strongly with the Data Re-Use GPO and deliver use-cases to address the deficiencies and opportunities that exist to further maximise the value from Data Re-Use

Key Responsibilities:

The Biostatistics Data Asset Governance lead is accountable:

  • To take over data product ownership for Biostatistics into DAFS
  • To assign data governance roles and ensure clear responsibility for ownership and stewardship for data assets
  • To engage with a range of stakeholders, ensuring they are adequately trained, mentored, and supported in their roles as Data Owners, Data Stewards, and Data Users
  • To engage with industry leaders, regulatory agencies, and consortiums and identify topics for internal discussions, broaden and challenge scope of thinking to inform data governance to answer important scientific questions
  • To facilitate communication and negotiation with leadership and other key strategy stakeholders, including regular reports and strategy progress meetings

Leadership and Strategy:

  • To develop vision and strategy for the design and implementation the Data Governance Framework for Reported Clinical Trial Data, with a focus on measuring and improving data quality, and the protection of data in alignment to Biostatistics strategy

Business Partnerships:

  • To cultivate strong collaborations with partner functions
  • To enable transparency (between Business, R&D Tech, enterprisewide data governance, risk management, data policy and legal groups) to ensure alignment of strategies, achieve business objectives/outcomes and maintenance of service levels in line with business need
  • To manage relationships with vendors and external resources to enable the strategy delivery of the DAFS portfolio

Business and Organizational Leadership:

  • To define, measure and monitor indicators of data lifecycle performance and quality to ensure compliance with data policies and standards
  • To report on risks, issues, and performance to senior s


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