Senior Director, Biostatistics

Summary

Join Ultragenyx as a Senior Director of Biostatistics and make a difference in rare disease treatment. You will lead statistical efforts for product deliverables, provide strategic input to clinical programs, and ensure regulatory compliance. This remote position requires a PhD in Statistics or Biostatistics with extensive experience in clinical trials and regulatory submissions. You will collaborate with cross-functional teams, conduct analyses, and develop department standards. Ultragenyx offers a competitive salary, annual bonus, equity incentives, and a comprehensive benefits package including generous vacation time, volunteer days, and professional development opportunities.

Requirements

• PhD in Statistics or Biostatistics with a minimum of 13 years (minimum 15 years for master’s degree) of postgraduate experience in the clinical trials setting in the pharmaceutical industry
• Experience leading NDA/BLA/MAA activities from statistical perspective, including direct regulatory interactions
• Experienced as product lead statistician and contributing to strategy discussion in cross functional settings; Experienced in managing multiple products and studies and being able to prioritize; Prior experience in Rare Disease clinical development is preferred
• Experienced in study level work including authoring SAP and TFL specification
• Excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, SAS programming, and other relevant software applications, statistical methodologies, theories, and analysis including adaptive designs and Bayesian analysis
• Familiar with ICH guidelines, FDA/EMA/other regulatory authority guidance
• Excellent communication and interpersonal skills
• Detailed-oriented with organization, problem solving and prioritization skills
• Familiar with SAS and R; knowledge of CDISC including SDTM, ADaM, and controlled terminologies

Responsibilities

• Contribute to study level tasks from statistical perspective, including but not limiting to: input to study design and sample size determination; author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings
• Lead product level tasks including regulatory interactions and filings, ensuring statistical integrity; contribute strategically to Ultragenyx projects from statistical perspective
• Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
• Translate statistical thinking into strategic input to advance the clinical program
• Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
• Lead developing department standards and research in advanced statistical methodologies
• Author/review regulatory documents or scientific publications
• Oversee work by CRO and ensure quality deliverables

Benefits

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Annual bonus
• Equity incentives