Senior Vice President, Biostatistics and Statistical Programming jobs in United States
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Ultragenyx · 3 months ago

Senior Vice President, Biostatistics and Statistical Programming

Ultragenyx Pharmaceutical is dedicated to leading the future of rare disease medicine by creating innovative treatments and fostering a collaborative environment. The Senior Vice President, Biostatistics and Statistical Programming will oversee the statistical aspects of clinical trials and lead the Biostatistics/Epidemiology and Statistical Programming teams, ensuring the integrity of clinical studies and contributing to strategic planning for clinical programs.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

. in BiostatisticsStatistical analysisBayesian data analysesEpidemiological methodologyClinical trial designRegulatory guidanceManagement skillsCollaboration skillsCommunication skills

Required

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

Company

Ultragenyx

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Leading with purpose. Every day.

H1B Sponsorship

Ultragenyx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (10)
2023 (17)
2022 (16)
2021 (16)
2020 (4)

Funding

Current Stage
Public Company
Total Funding
$1.54B
Key Investors
Ontario Municipal Employees Retirement SystemAdage Capital Management
2025-11-04Post Ipo Debt· $400M
2024-06-13Post Ipo Equity· $350M
2023-10-18Post Ipo Equity· $300M

Leadership Team

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Emil Kakkis
Founder, Chief Executive Officer and President
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Howard Horn
Chief Financial Officer and Executive Vice President, Corporate Strategy
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Company data provided by crunchbase