Principal Biostatistician (Pharma)

Copenhagen, Capital Region
Posted 1 week ago
Data Science

About the role

Job summary

The role involves providing comprehensive statistical leadership and integration support for Phase II and Phase III clinical trials, collaborating with various stakeholders in a dynamic environment.

Qualifications

  • Significant experience as a Principal Biostatistician in the pharmaceutical or contract research organization sector.
  • In-depth knowledge of Phase II and III clinical studies.
  • Proven ability in authoring and reviewing Statistical Analysis Plans (SAP).
  • Capability to work independently with minimal oversight.
  • Strong communication skills, with a proactive and solution-oriented approach.
  • Experience in Immunology therapeutic area is beneficial but not required.
  • Proficient in R Programming.

Responsibilities

  • Deliver Principal-level biostatistical support for clinical trials in Phases II and III.
  • Lead the authoring and review of SAPs independently.
  • Support integration activities across various studies and programs.
  • Serve as a proactive statistical partner to Clinical, Programming, and Regulatory teams.
  • Ensure the timely delivery of high-quality and compliant statistical outputs.
  • Communicate effectively with both internal and external stakeholders.
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