Biostatistics Director- Global BIOS

Join us on our exciting journey! IQVIA’s Center for Statistics in Drug Development (CSDD) Group is hiring! This is an exciting group that sits within IQVIA’s Core Services Research and Development Business Unit. Apart of the larger Biostatistics Team, this team is unique in its emphasis on helping clinical researchers to navigate the complexities of trial designs, endpoint selection, sample size estimation, analysis methods, data displays, and interpretations by applying deep statistical expertise.

Our seasoned biostatisticians serve as statistical consultants, both internally and externally, and their early engagement helps identify gaps in the drug development strategy and in individual protocols — at the time of synopsis writing. Our expertise in design types include biosimilars, adaptive designs, dose-response designs, master protocols, Bayesian analyses etc.

As a Director, Biostatistics, you will serve as a thought leader in statistical methodology for clinical trial design. You will serve as a 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. You 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. Management responsibilities can be tailored to the interest of the candidate. This position can be either home- or office-based. Position level depends on experience.

PhD or MSc degree in Statistics, Biostatistics, or related field, along with 11 to 13+ years’ experience within the life-science industry, PhD preferred or equivalent experience. 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 experience interact with regulatory bodies and compliance within the pharmaceutical and CRO space.

FDA experience is preferred. Working knowledge of SAS and CDISC SDTM and ADaM Ability to effectively manage multiple tasks and project, ability to communicate and explain statistics Experience preparing budgets/proposals and participating in bid defences and Experience in teaching Statistics preferred. Experience publishing papers or presenting talks at scientific conferences and/or in webinars.

Interesting and innovative projects Collaborative and inspirational working environment / atmosphere Excellent career development and progression opportunities Work – life balance

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…