[Remote] Senior Vice President, Biostatistics and Statistical Programming

Note: The job is a remote job and is open to candidates in USA. Ultragenyx is a biopharmaceutical company focused on developing innovative treatments for rare diseases. The Senior Vice President, Biostatistics and Statistical Programming will lead the statistical aspects of clinical trials and oversee the Biostatistics/Epidemiology and Statistical Programming teams, ensuring statistical integrity and strategic planning for clinical programs.

Responsibilities

• Lead the Biostatistics/Epidemiology and Statistical Programming teams
• Ensure statistical integrity of clinical studies conducted to support projects across the portfolio
• Set strategy for the department, including enhancing technical expertise in support of drug development and enabling development of staff
• Build/drive relationships and teamwork across the Biostatistics and Programming teams in support of the programs ensuring proper statistical strategies, and understanding of priorities between the project teams and the teams
• Provide statistically/epidemiologically sound scientific methodology leadership in experimental design and data analyses
• Review statistical analysis sections of protocols, statistical analysis plans, study reports, regulatory documents or scientific publications, generates/reviews study sample size/power estimations
• Provide leadership in the interpretation and reporting of the results of statistical analyses
• Mentor lead statisticians/epidemiologists in presenting the statistical concepts, evidence, interpretations, and logical arguments to the project team and senior management
• Independently pursue analyses suggested by the data; Propose new/novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results
• Contribute to the advancement of research in clinical trials methodology. Establish a healthy culture in the department, including collaboration and quality mindset
• Develop and evaluate options for meeting project team goals under time and budgetary constraints and can change course quickly

Skills

• Ph.D. in Applied Statistics, Statistics, or Biostatistics
• 20+ years of experience applying statistics and epidemiology methods in a biopharmaceutical industry
• Demonstrated statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, analysis of clinical imaging results such as X-Ray
• Experience in designs and Bayesian data analyses, rare disease global clinical development and applying epidemiological methodology to support delivering rare disease therapies for patients
• Has influenced external environment through contributions to presentations, and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical and epidemiological methodologies
• Experience in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators
• Experience with regulatory guidance and guidelines, and general knowledge of industry best practices. Expert knowledge in Health Authority interactions and submission strategies, IND/BLA/NDA/MAA submissions, and writing technical and management documents

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
• Benefits vary by region and country

Company Overview

• Leading with purpose. Every day. It was founded in 2010, and is headquartered in Novato, California, USA, with a workforce of 1001-5000 employees. Its website is http://www.ultragenyx.com.

Company H1B Sponsorship

• Ultragenyx has a track record of offering H1B sponsorships, with 11 in 2025, 10 in 2024, 17 in 2023, 16 in 2022, 16 in 2021, 4 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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