Biostatistics Director- Global BIOS

NCBioImpact; Durham (NC); Hybrid; USD 135,000 - 376,000; Full time

Benefits offered by this job

Interesting projects

Collaborative environment

Career development

Work–life balance

Job summary

IQVIA’s Center for Statistics in Drug Development (CSDD) is hiring a Director, Biostatistics, to lead statistical methodology for clinical trial design as part of a consultancy team. You will guide internal and external clients, specialize in key areas of leadership, and may join data monitoring committees as needed.

You may work from home or the office; travel to clients is possible. Strong experience in biosimilars, adaptive designs, master protocols, Bayesian methods, and regulatory awareness

Qualifications

• PhD or MSc in Statistics/Biostatistics with 11–13+ years in life sciences (PhD preferred).
• Expertise in complex statistical methods for clinical trials.
• Experience with regulatory bodies; FDA experience preferred.
• Strong ability to manage multiple tasks and communicate statistics clearly.
• Experience publishing papers or presenting at scientific conferences and/or webinars.

Responsibilities

• Provide high-level statistical leadership for clinical trial design and related analyses.
• Lead the development of protocol synopses with cross-disciplinary teams.
• Contribute to full protocols and advanced statistical analyses as needed.
• Publish papers, give talks at conferences, and participate in webinars.

Skills

Statistical leadership

Clinical trial design

Regulatory knowledge

Budgeting/ proposals

Bid defences

Statistics communication

Education

PhD in Statistics/Biostatistics

MSc in Statistics/Biostatistics

Tools

SAS

CDISC SDTM/ADaM

Job description

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.

Job Overview

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.

Requirements

• PhD or MSc degree in Statistics, Biostatistics, or related field, along with 11 to 13+ 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
• 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 publishing papers or presenting talks at scientific conferences and/or in webinars

What is in it for you?

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

Whatever your career goals, we are here to ensure you get there!

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $134,800.00 - $375,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.