[Remote] Senior Vice President, Biostatistics and Statistical Programming

Note: The job is a remote job and is reputed company 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 reputed company the statistical aspects of clinical trials and reputed company the Biostatistics/Epidemiology and Statistical Programming teams, ensuring statistical reputed company and strategic planning for clinical programs.

Responsibilities

• reputed company the Biostatistics/Epidemiology and Statistical Programming teams
• Ensure statistical reputed company 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
• reputed company 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
• reputed company leadership in the interpretation and reporting of the results of statistical analyses
• Mentor reputed company 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 reputed company
• reputed company 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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