Senior Director, Biostatistics

The Role: 

The Senior Director, Biostatistics is a statistical leader responsible for defining and executing statistical strategy for late-stage development program, and regulatory readiness. This Senior Director, Biostatistics will report to Head of Biometrics and expected to partner closely with Clinical Development, Regulatory Affairs, Translational Medicine, and Clinical Pharmacology to ensure scientific rigorous trial execution, and informed decision-making from early development through registration.  

The Senior Director will be directly responsible for critical statistical deliverables, demonstrating both strategic leadership and hands-on ownership and ensuring alignment across internal teams and external partners.  

Here's how you'll contribute: 

• Lead statistical strategy across clinical programs to align with development objectives and regulatory expectations. 

• Provide statistical leadership for late-stage development, including pragmatic application of adaptive, Bayesian, or innovative designs where appropriate. 

• Draft and review SAPs, statistical components of protocols, regulatory submissions, and support regulatory interactions with global health authorities. 

• Mentor and develop a high-impact biostatistics team, including coaching, mentoring and performance feedback. 

• Collaborate with Biometrics leadership to establish, implement and enforce statistical standards, processes, and best practices. 

• Ensure high-quality, timely execution of statistical analyses in collaboration with cross-functional teams. 

• Apply advanced methodologies, including modeling and simulations to inform quantitative decision making while balancing feasibility, timelines, and scientific rigor. 

• Translate complex statistical concepts into clear, aligned, and decision-oriented communication for cross-functional teams and senior leadership. 

Leadership Responsibilities 

• Set and uphold clear expectations for accountability, ownership, and professional conduct. 

• Develop and coach team members with an emphasis on evidence-based decision making, collaboration, and execution discipline. 

• Model professional, calm engagement during high-stakes, scientific, and regulatory discussions. 

• Encourage innovation within a framework of governance, transparency, and risk awareness. 

• Communicate transparently, clearly, and constructively with senior leadership and external stakeholders. 

The Ideal Candidate will have:

• PhD in Statistics/Biostatistics with 12+ years in biotech/pharma, or MS with 15+ years. 

• Prior biostatistics leadership experience in respiratory disease, with direct involvement in at least one <