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 strategic input for regulatory submissions.
• Collaborate with cross-functional teams.
• Ensure statistical integrity of deliverables.
• Develop advanced statistical methodologies.
• Manage multiple products and studies.
• Conduct analyses and propose novel approaches.
• Oversee work by CROs.
• Author and review regulatory documents.
• Participate in study design and sample size determination.

Requirements

• PhD in Statistics or Biostatistics.
• Minimum 13 years of experience in clinical trials.
• Experience with NDA/BLA/MAA activities.
• Excellent statistical knowledge and software skills.
• Familiarity with ICH guidelines and regulatory authority guidance.
• Strong communication and interpersonal skills.
• Detail-oriented with problem-solving skills.
• Knowledge of SAS and R.
• Experience in Rare Disease clinical development preferred.
• Ability to prioritize and manage multiple projects.

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.