Director, Biostatistics

Ultragenyx

Director of Biostatistics at Ultragenyx Pharmaceutical provides technical leadership on clinical studies. Responsible for statistical analyses, project management, and mentoring junior team members.

Posted 7/8/2026full-timeRemote • 🇺🇸 United StatesLead💰 $220,700 - $272,700 per yearWebsite

About the role

Key responsibilities & impact

Lead in product / indication level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
Contribute to study level tasks from statistics perspective, including: 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
Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
Contribute to developing standards and research in advanced statistical methodologies
Author/review regulatory documents or scientific publications
Mentor junior team members

Requirements

What you’ll need

PhD in Statistics or Biostatistics with a minimum of 8 years (min 11 years for Masters) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction
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
Experienced in study level work including authoring SAP and TFL specification
Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
Solid understanding of mathematical and statistical principles; Experience in statistical methods analyzing longitudinal data is preferred
Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline
Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

Statistical MethodologyStudy DesignSample Size DeterminationStatistical Analysis Plan (SAP) AuthoringTFL Specification DevelopmentData RandomizationStatistical Integrity AssuranceRegulatory Document AuthoringAdvanced Statistical MethodologiesClinical Trials Experience

Soft Skills

Detail-OrientedOrganizational SkillsProblem SolvingPrioritization SkillsCollaboration