Director Biostatistics, Clinical Operations

AskBio, a Bayer AG subsidiary, is recruiting a Director of Biostatistics to lead clinical operations strategy across our gene therapy portfolio in the United States. This full-time position offers the opportunity to shape statistical approaches for innovative programs targeting serious neurological, cardiac, and metabolic conditions.

About the Role

In this senior leadership position, you'll oversee the biostatistics function for our clinical portfolio, ensuring rigorous study design, regulatory compliance, and data integrity across all development programs. You'll serve as the statistical authority guiding trial strategy, working closely with clinical development, regulatory affairs, and research teams to advance breakthrough therapies from design through regulatory approval.

What You'll Do

• Design statistical strategies, protocols, and analysis plans for clinical trials across therapeutic areas
• Ensure compliance with FDA regulations, ICH guidelines, and international regulatory requirements
• Lead, mentor, and develop a high-performing biostatistics team
• Oversee data quality, database management, and biostatistical analysis
• Support preparation and review of regulatory submissions and agency communications
• Advance statistical methodologies tailored to gene therapy development
• Collaborate with cross-functional teams to drive operational excellence

What We're Looking For

• Graduate degree (MS or PhD) in Biostatistics, Statistics, or a closely related field
• Extensive experience in clinical biostatistics within pharmaceutical or biotech environments
• Deep expertise in regulatory affairs, FDA submissions, and compliance frameworks
• Demonstrated leadership managing and mentoring statistical teams
• Excellent written and verbal communication for cross-functional stakeholder engagement
• Experience in gene therapy, rare disease, or specialty therapeutic development is valued

About AskBio

AskBio is an independently operated gene therapy company within the Bayer group, committed to discovering and developing transformative medicines. Our clinical portfolio spans multiple serious disease indications, and we're advancing programs designed to offer hope to patients with limited therapeutic alternatives.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.