Principal Biostatistician, Medical Affairs - Remote

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

Benefits offered by this job

Home-based

Flexible schedules

Career development

Research opportunities

Long-term engagements

Regulatory submissions

Job summary

IQVIA is seeking a Principal Biostatistician (FSP) for Phase 2/3 pharmaceutical research, offering a home-based opportunity in the U.S. or Canada. The role focuses on statistical analysis support, collaboration with cross-functional sponsor teams, and publications.

The position emphasizes independence, strong communication, and supervision of programmers, with training and development opportunities and a focus on regulatory submissions.

Qualifications

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

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
• Author statistical analysis plans.
• Collaborate with Biostatistics, Statistical Programming, Clinical Development, and Clinical Operations 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 statistical outputs (tables, listings and figures) using SAS or R
• Interpret study results and review reports of study results for accuracy.
• Support exploratory analyses.

Skills

Statistical analysis

Independent work

Communication

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

R

SAS

CDISC

SDTM

ADAM

CDASH

Job description

IQVIA is seeking a Principal Biostatistician (FSP) for Phase 2/3 pharmaceutical research, offering a home-based opportunity in the U.S. or Canada. The role focuses on statistical analysis support, collaboration with cross-functional sponsor teams, and publications.

The position emphasizes independence, strong communication, and supervision of programmers, with training and development opportunities and a focus on regulatory submissions.