Remote Principal Biostatistician for Phase 2/3 Trials

IQVIA; Durham (NC); Remote; USD 96,000 - 309,000; Full time

Benefits offered by this job

Home-based remote working

Flexible schedules

Technical training & development

Collaboration with high-performance团队

Research opportunities

Career progression opportunities

Job stability and long-term engagement

Regulatory submission experience

Job summary

IQVIA seeks a Principal Biostatistician to provide statistical support for pharmaceutical trials. The role is home-based in the U.S. or Canada and centers on study design, power calculations, and analysis planning with cross-functional teams.

You will contribute to regulatory submissions, guide programming teams, and participate in study reports. A PhD or MS with substantial industry experience is required.

Qualifications

• PhD or MS with extensive industry experience in biostatistics.
• Experience supporting Phase 2/3 trials and regulatory submissions.
• Proactive, independent worker with strong communication skills.
• Ability to use R or SAS for analyses and programming.
• Familiarity with CDISC standards and estimands/multiple imputation.

Responsibilities

• Collaborate with multi-disciplinary teams to define objectives and timelines.
• Perform sample size and power calculations for study design.
• Author statistical analysis plans and TLF specifications.
• Supervise programmers in dataset specs and validation of tables/listings/figures.
• Interpret results and contribute to clinical study reports and regulatory documents.
• Support IND/NDA activities and monitor CRO timelines.

Skills

Statistical analysis

Independent work

Cross-functional collaboration

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

R

SAS

CDISC (SDTM/ADAM/CDASH)

Job description

IQVIA seeks a Principal Biostatistician to provide statistical support for pharmaceutical trials. The role is home-based in the U.S. or Canada and centers on study design, power calculations, and analysis planning with cross-functional teams.

You will contribute to regulatory submissions, guide programming teams, and participate in study reports. A PhD or MS with substantial industry experience is required.