Position Summary:

ultraimpact – Make a difference for those who need it most

The Senior Director of Biostatistics acts as statistical lead with accountability for Ultragenyx product and study deliverables; Provides strategic input and statistical expertise in advancing clinical programs; Able to apply both innovative and pragmatic statistical approaches to projects and activities in alignment with Ultragenyx objectives and priorities; Provide statistical leadership for regulatory submissions, including authoring and reviewing statistical sections of regulatory documents to FDA or other regulatory agencies and represent the company at meetings; Lead implementation of strategies and goals for the Biostatistics and Epidemiology group within the broader Data Sciences and Development Strategy organization.

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Contribute to study level tasks from statistical perspective, including but not limiting to: input to 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
• Lead product level tasks including regulatory interactions and filings, ensuring statistical integrity; contribute strategically to Ultragenyx projects from statistical perspective.
• Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
• Translate statistical thinking into strategic input to advance the clinical program.
• Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results.
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements.
• Lead developing department standards and research in advanced statistical methodologies.
• Author/review regulatory documents or scientific publications
• Oversee work by CRO and ensure quality deliverables.

Requirements:

• PhD in Statistics or Biostatistics with a minimum of 13 years (minimum 15 years for master’s degree) of postgraduate experience in the clinical trials setting in the pharmaceutical industry.
• Experience leading NDA/BLA/MAA activities from statistical perspective, including direct regulatory interactions.
• 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; Prior experience in Rare Disease clinical development is preferred.
• Experienced in study level work including authoring SAP and TFL specification.
• Excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, SAS programming, and other relevant software applications, statistical methodologies, theories, and analysis including adaptive designs and Bayesian analysis.
• Familiar with ICH guidelines, FDA/EMA/other regulatory authority guidance.
• Excellent communication and interpersonal skills
• Detailed-oriented with organization, problem solving and prioritization skills.
• Familiar with SAS and R; knowledge of CDISC including SDTM, ADaM, and controlled terminologies. #LI-CS1 #LI-Remote