Principal Biostatistician (Remote) Phase 2/3 Analytics Lead

IQVIA Inc; Durham (NC); Remote; USD 111,000 - 309,000; Full time

Benefits offered by this job

Remote work

Flexible schedules

Career development

Job summary

IQVIA Inc. seeks a Principal Biostatistician (FSP) to provide statistical analysis support for pharmaceutical research in Phase 2 and 3 trials. This home-based role offers remote work within the U.S.

or Canada, with opportunities to collaborate across sponsor teams and contribute to publications and regulatory submissions. You will author SAPs, supervise programmers, and independently generate and validate outputs using SAS or R, while ensuring compliance with ICH GCP/E9 and CDISC standards.

Qualifications

• PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
• MS in Statistics, Biostatistics, or related field with 7+ years industry experience.
• At least 3 years in Phase 2/3 clinical trial experience.
• Ability to work proactively and independently in a fast-paced environment.
• Able to effectively communicate ideas and manage programmers constructively.
• Ability to use R or SAS to perform efficacy and safety analyses and validate data derivations.
• Understanding of ICH GCP, ICH E9 and general industry practices and standards.
• Experience with CDISC, including SDTM, ADAM, CDASH.

Responsibilities

• Collaborate with multi-disciplinary project teams to establish objectives and timelines.
• Author statistical analysis plans.
• Collaborate across departments to provide statistical expertise.
• Contribute to publications and presentations.
• Provide guidance and supervision to programmers in planning and execution of analysis.
• Independently program or validate outputs (tables,Listings,Figures) using SAS or R.
• Interpret study results and review reports for accuracy.
• Support exploratory analyses.

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

R

SAS

CDISC (SDTM/ADaM/CDASH)

Job description

IQVIA Inc. seeks a Principal Biostatistician (FSP) to provide statistical analysis support for pharmaceutical research in Phase 2 and 3 trials. This home-based role offers remote work within the U.S.

or Canada, with opportunities to collaborate across sponsor teams and contribute to publications and regulatory submissions. You will author SAPs, supervise programmers, and independently generate and validate outputs using SAS or R, while ensuring compliance with ICH GCP/E9 and CDISC standards.