Remote Director, Biostatistics

Summary

Join our team at Ultragenyx as we tackle rare and dynamic challenges in the field of biopharma. As a Director of Biostatistics, you will lead product/indication level tasks, contribute to study design, and ensure statistical integrity. If you want to have a meaningful impact, do the best work of your career, and grow both professionally and personally, come join our team.

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