Principal Biostatistician , Medical Affairs (fsp -permanent Homebased)

IQVIA

Multiple Locations
Statistical planning and analysis
Regulatory submissions support
Sas or r expertise
Drive quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions

Job Summary

  • Drive quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions.
  • Serve as a biostatistical consultant for other members of the department and represent sponsors at meetings with regulatory agencies.
  • Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements.

Matching Summary

Drive quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions.

Skills & Requirements

Must-have

  • Statistical planning and analysis
  • Regulatory submissions support
  • SAS or R expertise
  • CDISC Data Standards knowledge
  • Clinical trial methodology

Nice-to-have

  • Independent research activities
  • Teaching opportunities
  • Manuscript preparation
  • Pro-active problem solving

Key Requirements

  • Masters or PhD degree
  • Relevant experience in life-science industry
  • Expertise in complex statistical methods
  • Experience as statistical lead for regulatory submissions
  • Knowledge of GCP and ICH guidelines
  • Work authorization not specified

Work Rights

Not specified

Tailored Resume

Cover Letter