Biostatistics Director, CSDD
Descripción del trabajo
Join us on our exciting journey!
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 a Director, Biostatistics you will lead a team of staff serving in statistical consultancy roles, providing support to both internal and external clients.
Each member of the team is expected to specialize in at least one area of statistical leadership and serve as subject matter expert but is also expected to consult in a broader capacity, depending on the consulting needs.
You may also be a member of data monitoring committees, either as blinded or unblinded statistician.
Our remit is clinical trial and program design and advanced data analyses or analytics and provide consulting in advanced statistical analyses.
Team members will help write protocol synopses for clients as part of a team which includes medical, regulatory, pharmacokinetic, and operational experts.
Occasionally we may contribute to full protocols.
Trial designs of particular interest include biosimilars, adaptive designs, master protocols, Bayesian analyses, and related statistical methods.
Thought leadership is also expected from team members, which includes publishing papers in peer-reviewed journals, refereeing and editorial work, presenting talks at scientific conferences, and participating in our by-invitation-only webinars.
This position can be either home- or office-based.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's Degree in Biostatistics or related field and 12 years relevant experience including 4 years’ experience managing staff or a Master's Degree in Biostatistics or related field and 8 years relevant experience including 4 years’ experience managing staff or a Ph.D. in Biostatistics or related field and 7 years relevant experience including 4 years’ experience managing staff
Strong knowledge of complex or advanced statistical methods and good expertise in implementing and applying them in clinical trials
Must have experience with clinical trial design, adaptive design strongly preferred
Must have solid work experience in regulatory health authorities’ environment (FDA, EMEA, etc.) and with compliance within the pharmaceutical and CRO space.
Strong working knowledge of SAS or R and CDISC SDTM and ADaM
Ability to effectively manage multiple tasks and projects, ability to excel at communicating and explaining statistical concepts
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!
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
Únase a la red de talentos de IQVIA
Regístrese hoy y le informaremos cuando haya puestos disponibles que coincidan con sus intereses profesionales.Únase a nuestra red