Associate Director - Center for Statistics in Drug Development
Descripción del trabajo
Associate Director -Center for Statistics in Drug Development
IQVIA’s Center for Statistics in Drug Development (CSDD) group is hiring!
This is a boutique expert statistical consulting group advising on exciting opportunities within IQVIA’s Core Services Research and Development Business unit.
Apart of the larger Biostatistics Team, this statistical research team is unique in its emphasis to develop optimal strategies to best navigate the complexities of clinical development, support building innovative and optimized trial designs, and facilitate decision-making throughout clinical development.
Our biostatisticians support endpoint selection, sample size estimation and re-estimation, simulations, advise on state-of-the art design approaches and analysis methods, and assist with data displays and interpretations of data analysis results, based on machine learning or other complex data analyses. Our experienced biostatisticians serve as statistical consultants, both internally and externally, provide statistical thought leadership, and advise on advanced statistical methods.
Their early engagement aims to identify gaps in the drug development strategy and in proposed study designs — at the time of synopsis writing.
The CSDD group’s expertise in design types include biosimilars, adaptive designs, seamless designs, dose-response designs, master protocols, Bayesian methods and analyses.
This group engages in publishing papers in peer-reviewed journals, refereeing and editorial work, and presenting talks at scientific conferences and at internal and external webinars.
As an Associate Director, Biostatistics, you will serve as a thought leader in statistical methodology for clinical trial design and will be part of a larger team in a statistical consultancy role, providing high level guidance to both internal and external clients.
Each member of the team is expected to specialize in at least one area of statistical leadership and will serve as subject matter expert.
You will lead that associated body of work as well as fulfil general consulting roles as needed and may also be a member of data monitoring committees, either as blinded or unblinded statistician.
Our remit is trial and program design, along with associated analyses. Team members will help write protocol synopses for clients as part of a team which includes medical, pharmacokinetic, and operational experts. Occasionally we may contribute to full protocols and provide consulting in advanced statistical analyses. Trial designs of particular interest include biosimilars, adaptive designs, master protocols, Bayesian analyses, and related statistical methods.
Thought leadership is expected from team members, which includes publishing papers in peer-reviewed journals, referee, and editor work, presenting talks at scientific conferences, and participating in our by-invitation-only webinars. Management of people and projects is also possible depending on interest. Participation in bid defences is expected, as is some travel to clients.
With regional/site presence, you will manage a team of Biostatistics staff and fulfil the role of site head or functional head within a site.
You will also provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work. Coupled with, serving as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials and assist the Director in strategic planning and resource allocation for the department.
PhD or MSc degree in Statistics, Biostatistics, or related field, along with 10 + years’ experience within the life-science industry, PhD preferred.
Strong knowledge of complex statistical methods that apply to applicable clinical trials
Must have experience with clinical trial design, adaptive design strongly preferred
Must have some knowledge of regulatory bodies and compliance within the pharmaceutical and CRO space. FDA experience is preferred.
Strong working knowledge of SAS and CDISC SDTM and ADaM
Embrace your curiosity and grow your career in an exciting environment where development is a priority.
Think boldly and disrupt conventional thinking.
Enjoy what you do.
Whatever your career goals, we are here to ensure you get there!
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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