Remote Principal Biostatistician – Clinical Trials

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

Benefits offered by this job

Home-based remote work

Flexible schedules

Professional development

Research opportunities

Long-term engagements

Job summary

IQVIA's Data Sciences Staffing Solutions unit seeks a Principal Biostatistician to provide statistical support for pharmaceutical clinical trials. The position is home-based in the U.S.

or Canada, enabling collaboration with sponsor teams and contribution to study design, regulatory submissions, and analysis plans. You will lead SAS/R analyses, develop TLFs, oversee programmers, and ensure accuracy of results for IND/NDA dossiers.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 3+ years of industry experience.
• MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• At least 2 years in Phase 2/3 clinical trial experience.
• At least 3 years of experience in supporting simulations, sample size and power calculations
• Demonstrated ability to work pro-actively and independently.
• Able to effectively communicate statistical ideas and collaborate with cross-functional teams.

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Perform samples size and power calculations for optimizing study design.
• Author statistical analysis plans.
• Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
• Author or review analysis dataset and TLF specifications
• Validation programming of efficacy analysis datasets plus tables, listings, and figures (TLF)
• Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures for safety, etc.
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.
• Participate in IND or NDA activities.
• Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
• Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, SCE (Summary of Clinical Efficacy), SCS (Summary of clinical Safety).

Skills

Statistical analysis

Cross-functional communication

R or SAS

Regulatory submissions

IND/NDA experience

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

R

SAS

ADAM

TLF

CDISC (SDTM/ADAM/CDASH)

Job description

IQVIA's Data Sciences Staffing Solutions unit seeks a Principal Biostatistician to provide statistical support for pharmaceutical clinical trials. The position is home-based in the U.S.

or Canada, enabling collaboration with sponsor teams and contribution to study design, regulatory submissions, and analysis plans. You will lead SAS/R analyses, develop TLFs, oversee programmers, and ensure accuracy of results for IND/NDA dossiers.