Director, Biostatistics & Trial Design (Hybrid/Remote)

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

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