Senior Director of Biostatistics - Remote

Overview

The Senior Director of Biostatistics acts as statistical lead with accountability for Ultragenyx product and study deliverables, providing strategic input and statistical expertise in advancing clinical programs.

In Short

• Lead statistical efforts for clinical programs.
• Provide statistical leadership for regulatory submissions.
• Collaborate with cross-functional teams for product deliverables.
• Conduct statistical analyses and propose novel methodologies.
• Ensure statistical integrity of deliverables.
• Oversee work by CROs for quality deliverables.
• Author and review regulatory documents.
• Develop department standards in statistical methodologies.
• Contribute to study design and sample size determination.
• Participate in strategic discussions for product development.

Requirements

• PhD in Statistics or Biostatistics with 13+ years of experience.
• Experience with NDA/BLA/MAA activities.
• Product lead statistician experience.
• Familiarity with ICH guidelines and regulatory authority guidance.
• Strong SAS and R programming skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong organizational skills.
• Experience in Rare Disease clinical development preferred.
• Knowledge of CDISC standards.
• Ability to work independently and collaboratively.

Benefits

• Generous vacation time and public holidays.
• Volunteer days.
• Long-term incentive and employee stock purchase plans.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.