Biostatistics Director- Global BIOS

IQVIA; Durham (NC); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Interesting projects

Collaborative environment

Career progression

Work-life balance

Job summary

IQVIA's Center for Statistics in Drug Development (CSDD) seeks a Director, Biostatistics to lead statistical design and consultancy for clinical trials, partnering with internal and external clients. You will guide teams on complex methods, write protocol synopses, contribute to full protocols, publish findings, and oversee budgets and bids, with opportunities for leadership and travel.

This role offers a blend of home- and office-based work in a dynamic global environment, with career

Qualifications

• PhD or MSc degree in Statistics/Biostatistics or related field with 11–13+ years in life-science industry.
• Strong knowledge of complex statistical methods applicable to clinical trials.
• Experience with clinical trial design; adaptive design strongly preferred.
• Knowledge of regulatory bodies and compliance in pharmaceutical/CRO space; FDA experience preferred.
• Strong working knowledge of SAS and CDISC SDTM and ADaM.
• Ability to manage multiple tasks and projects and communicate statistics effectively.
• Experience preparing budgets/proposals and participating in bid defenses.
• Experience publishing papers or presenting talks at scientific conferences or webinars.

Responsibilities

• Lead a body of work as a statistical leader and subject matter expert.
• Provide high-level statistical consultation to internal and external clients.
• Contribute to trial designs, protocol synopses, and potentially full protocols and advanced analyses.
• Publish papers, present at conferences, and participate in webinars.
• Possibly participate in data monitoring committees and travel to clients.

Skills

SAS

CDISC SDTM

ADaM

Statistical leadership

Clinical trial design

Budgeting

Bid defences

Scientific publishing

Education

PhD or MSc in Statistics/Biostatistics

Tools

SAS Software

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

JOIN US

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 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.

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