# Director, Biostatistics

**Company**: IQVIA
**Location**: Durham, North Carolina, North Carolina
**Experience**: senior
**Job type**: full-time
**Salary**: $134,800.00 - $375,700.00
**Category**: Research
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Durham-North-Carolina-United-States-of-America/Biostatistics-Director--Global-BIOS_R1577817?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

IQVIA's Center for Statistics in Drug Development (CSDD) Group is seeking a Director, Biostatistics. 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.

The team's remit is trial and program design, along with associated analyses. You will help write protocol synopses for clients as part of a team that includes medical, pharmacokinetic, and operational experts. Occasionally, you may contribute to full protocols and provide consulting in advanced statistical analyses.

Key areas of focus 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, refereeing and editing work, presenting talks at scientific conferences, and participating in webinars.

Responsibilities:

- Serve as a thought leader in statistical methodology for clinical trial design

- Provide high-level guidance to internal and external clients

- Specialize in at least one area of statistical leadership and serve as a subject matter expert

- Lead associated bodies of work and fulfill general consulting roles as needed

- Participate in data monitoring committees, either as a blinded or unblinded statistician

- Contribute to protocol synopses and occasionally full protocols

- Provide consulting in advanced statistical analyses

- Publish papers and present talks at scientific conferences

- Participate in webinars and bid defenses

Requirements:

- PhD or MSc degree in Statistics, Biostatistics, or a related field

- 11 to 13+ years of experience within the life-science industry

- Strong knowledge of complex statistical methods for clinical trials

- Experience with clinical trial design, adaptive design preferred

- Knowledge of regulatory bodies and compliance within the pharmaceutical and CRO space

- 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

Benefits:

- Interesting and innovative projects

- Collaborative and inspirational working environment

- Excellent career development and progression opportunities

- Work-life balance

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## Skills

### Required
- Statistics
- Biostatistics
- SAS
- CDISC SDTM
- ADaM
- Clinical trial design
- Adaptive design
- Regulatory compliance

### Nice to have
- FDA experience
- Publishing papers
- Presenting talks

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