Full-Time Senior Director, Biostatistics

Why Join Us? Be a hero for our rare disease patients. At Ultragenyx, we believe in taking impactful action to care for patients and our people. Our vision is to lead the future of rare disease medicine, challenging the status quo and creating a new model for advancement.

Position Summary: The Senior Director of Biostatistics acts as statistical lead for Ultragenyx product and study deliverables, providing strategic input and expertise in advancing clinical programs. They apply innovative and pragmatic statistical approaches aligned with Ultragenyx objectives. They lead regulatory submissions, author/review statistical sections, and represent the company at meetings. This role leads implementation of strategies for the Biostatistics and Epidemiology group within Data Sciences and Development Strategy.

Work Model: Remote, with occasional travel to offices.

Responsibilities:

• Contribute to study-level tasks, including input to design, sample size, protocol authoring/review, SAP and DMC charter, randomization files, TFL shell and specification, CRF review, and meeting participation.
• Lead product-level tasks, including regulatory interactions and filings, ensuring statistical integrity, and strategic contributions to Ultragenyx projects.
• Collaborate with biometrics and cross-functional teams for product deliverables and timelines.
• Translate statistical thinking into strategic input for clinical program advancement.
• Independently conduct analyses, propose new/novel approaches to improve study results, ensure statistical integrity, and provide sound scientific methodology.
• Lead developing department standards and research in advanced statistical methodologies.
• Author/review regulatory documents or scientific publications.
• Oversee CRO work and ensure quality deliverables.

Requirements:

• PhD in Statistics or Biostatistics with 13+ years (15+ for Master's) of postgraduate experience in clinical trials.
• Experience leading NDA/BLA/MAA activities from a statistical perspective, including regulatory interactions.
• Experience as a product lead statistician, contributing to cross-functional strategy discussions.
• Experience managing multiple products and studies, with prioritization skills.
• Preferred experience in Rare Disease clinical development.
• Experience in study-level work, including authoring SAP and TFL specifications.
• Excellent statistical knowledge, applying it to scientific and clinical problems, with experience in computational simulation, biomarker analysis, SAS programming, and other relevant software.
• Familiar with ICH guidelines, FDA/EMA guidance, SAS, R, and CDISC (SDTM, ADaM).
• Excellent communication, interpersonal, and detailed-oriented skills with strong organization, problem-solving, and prioritization skills.

Compensation: $245,000 - $302,600 USD (annual)

Benefits: Generous vacation, volunteer days, long-term incentives, employee stock purchase plans, employee wellbeing benefits, fitness reimbursement, tuition sponsorship, and professional development plans.

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