Director, Biostatistics

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare diseases, as their Director of Biostatistics. This remote position offers leadership in clinical study design, statistical analysis, and regulatory submissions. You will contribute to departmental standards, mentor junior team members, and collaborate with cross-functional teams. The ideal candidate possesses a PhD in Statistics or Biostatistics with extensive experience in clinical trials within the pharmaceutical industry, including NDA/BLA/MAA activities. Ultragenyx provides a supportive and inclusive work environment with a range of benefits.

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

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

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