Principal Biostatistician , Medical Affairs (fsp -permanent Homebased)

IQVIA Inc

Fully remote
Statistical methodology for clinical trials
Lead statistician on major projects
Develop/review protocols and analysis plans
IQVIA Inc is seeking a Principal Biostatistician for a home-based position to lead statistical planning, analysis, and reporting for pharmaceutical development and regulatory submissions. The ideal candidate should possess advanced expertise in biostatistics, experience with regulatory submissions, and strong collaboration skills

Job Summary

  • Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials.
  • Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.
  • Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses.

Matching Summary

Match Score: 85

IQVIA Inc is seeking a Principal Biostatistician for a home-based position to lead statistical planning, analysis, and reporting for pharmaceutical development and regulatory submissions. The ideal candidate should possess advanced expertise in biostatistics, experience with regulatory submissions, and strong collaboration skills.

Skills & Requirements

Must-have

  • Statistical methodology for clinical trials
  • Lead statistician on major projects
  • Develop/review protocols and analysis plans
  • Prepare/review integrated reports
  • Respond to regulatory queries
  • SAS or R expertise
  • CDISC Data Standards knowledge

Nice-to-have

  • Consultant for department members
  • Independent research and publications
  • Risk identification and mitigation
  • Database lock and unblinding leadership

Key Requirements

  • Masters or PhD degree in Biostatistics or related field
  • Relevant experience within life-science industry
  • Expert in complex statistical methods for Phase 2-3 trials
  • Experience as statistical lead for regulatory submissions
  • Knowledge of clinical research regulatory requirements, GCP, ICH
  • Work authorization in the specified region

Work Rights

Not specified

Tailored Resume

Cover Letter