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Statistics Director

3 months ago

Durham, North Carolina, United States ViiV Healthcare Full time


ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV.

ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV.

Our aim is to think, act, and connect differently through a focus on education on and treatment for HIV.

We go to extraordinary lengths to deliver the sorts of breakthroughs, both in treatments, care solutions and communities, that really count.

We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care.

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?

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Masters in Statistics or Biostatistics & 10 plus years of experience OR PhD & 5 plus years in statistics for drug development, including clinical development and/or post-marketing
5 plus years of leadership experience in a matrix environment, including influence and negotiation with the business
Experience leading Statistics aspects from study design to final analysis and dissemination
Direct experience in developing and delivering presentations & publications

Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Experience in advanced innovative statistical methodology
Effective verbal and written communication skills
Excellent interpersonal skills including relationship building and maintenance

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee.

Why Us?

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind.

Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.

We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently.

Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic.

We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe.

We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care.

As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.


Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities.

Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.

If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at US Toll Free) or outside US).

ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.

This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies


ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.

All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV.

The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV.

In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV.

ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment.

This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements.

For more information, please visit ViiV's Transparency Reporting For the Record site.
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