The Director of Biostatistics acts as program statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data quality assurance.

The Director of Biostatistics contributes to identifying, developing and implementing departmental standards, applications, processes and training. Provides timely support to the project teams on all statistical matters according to the project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level.

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:

• 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:

• 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 #LI-CS1 #LI-Remote