ViiV Healthcare (GSK) Statistics Director
GSKAbout the role
We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic. We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV isn’t just somewhere to work – it’s a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.
While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.
The Statistics Director will provide leadership and support relating to the Quantitative Data Sciences (Statistics) areas of statistics, statistical programming, and clinical data management for ViiV Healthcare (VH) for one or more programs.
This role is eligible for domestic relocation within the respective countries, US or UK.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Apply expertise relating to Statistics to specific products throughout their VH life cycle.
- Support Statistics product and project strategy in alignment with VH strategy.
- Proactively influence external opinion leaders and regulatory authorities related to Statistics methodology.
- Ensure Statistics product and project strategies are robust and effectively defended in interactions with senior internal groups and with regulatory authorities, external expert groups, lawyers and other companies.
- Responsible for the statistical validity of data dissemination related to supported programs.
- Prepare and deliver Headline Reports and related disseminations of results from VH clinical studies
- Lead and deliver asset level pooled/meta-analyses of internal and external clinical trials and observational data.
- Member of and key contributor to various VH teams (Medicine Development, Clinical Matrix, Global Collaborative Trials, Data Dissemination, etc…). Effective partnership with Medicines Development Leaders, Clinical Investigations Leaders, and others.
- Direct collaboration with and oversight of 3rd parties in fulfillment of responsibilities supporting VH programs, including capacity management and trouble-shooting problems related to project delivery
- Understand, assess and communicate Statistics aspects of project strategies & deliverables to key stakeholders.
- Provides statistics training and education to various areas of the company.
- Ensure appropriate interpretation and use of internal and external interventional and observational data.
- Support VH Head of Statistics and others in relationship to Statistics governance and procedural documentation, functional capability development, compliance, best practices, training and recruitment.
- Global (indirect) leadership and oversight of 3rd party suppliers of project level statistical and programming resource (eg GSK and Pfizer) to VH. Accountable for statistical (e.g., randomization/blinding/unblinding, protocol development, analysis planning, ADaM and TLF) deliverables and key milestones for supported projects. Consults with Programming and Data Management colleagues regarding deliverables relating to programming and data management activities, including but not limited to: database set up, data standards (CDISC), analysis database conversions (eg, ADaM), data repository, and data re-use.
- Statistical approval for regulatory correspondence, submissions, protocols, reports, and other deliverables.
- Statistical quality of relevant VH Medical Comments and related materials.
Why you?
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