Principal Biostatistician FSP – HTA

Overview

In this role you will lead statistical support for Phase I–IV trials within a sponsor-embedded setup, driving analytical strategies and collaboration with cross-functional teams. You will apply advanced statistical methods, incorporate machine learning, and oversee work across vendors to accelerate clinical development. You’ll shape study plans, ITC analyses, and HTA submissions, while mentoring statisticians and programmers. This role offers impact, autonomy, and the chance to advance patient treatment through rigorous analytics.

Pay / Benefits

• training and development support
• embedded sponsor role
• opportunity to influence clinical strategy

Responsibilities

• Provide statistical input into planning and analysis of ITC (Indirect Treatment Comparison)
• Support HTA dossier submission and negotiation
• Create specifications and perform time-to-event and longitudinal analyses
• Lead biostatisticians and statist programmers on statistical strategy and deliverables
• Develop and apply innovative statistical methodologies tailored to each project
• Collaborate with sponsor cross-functional teams and sponsor Biostatistics management
• Contribute to internal and external visibility of the company through expertise and client orientation

Key requirements

• PhD in Statistics or Master in Statistics (or related subject) with clinical trial experience
• Experience in statistical/biostatistical analysis supporting HTA activities
• Understanding of HTA guidelines
• Excellent verbal and written communication skills
• Ability to organize multiple work assignments and establish priorities
• Working SAS & R programming knowledge
• CDISC knowledge
• Experience in R is preferred

• strong communication
• team leadership
• prioritization and planning
• SAS
• R
• CDISC

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