Lead Biostatistician — Phase II/III & SAP Expert

IQVIA; København; On-site; DKK 673,000 - 972,000; Full time

Job summary

IQVIA is seeking a Principal Biostatistician to provide end-to-end statistical leadership for Phase II–III clinical trials. You will collaborate with cross‑functional stakeholders in a fast-paced global environment to drive high-quality statistical outputs and ensure timely delivery.

The role requires extensive experience in SAP writing/reviewing, strong R programming skills, and the ability to work independently.

Qualifications

• Strong experience as a Principal Biostatistician in Pharma or CRO.
• End-to-end knowledge of Phase II and III studies.
• Proven expertise in SAP writing and reviewing.
• Ability to work independently with minimal supervision.
• Proactive, solution-oriented communicator.
• Medical Affairs TA experience is a plus but not required.
• Strong R programming experience.

Responsibilities

• Provide Principal-level Biostatistics support for Phase II–III clinical trials.
• Independently lead SAP authoring and review.
• Support integration activities across studies and programs.
• Act as a proactive statistical partner to Clinical, Programming, and Regulatory teams.
• Ensure delivery of high-quality, compliant statistical outputs within timelines.
• Communicate clearly with internal and external stakeholders.

Skills

SAP writing

R programming

Independent work

Communication

Job description

IQVIA is seeking a Principal Biostatistician to provide end-to-end statistical leadership for Phase II–III clinical trials. You will collaborate with cross‑functional stakeholders in a fast-paced global environment to drive high-quality statistical outputs and ensure timely delivery.

The role requires extensive experience in SAP writing/reviewing, strong R programming skills, and the ability to work independently.