Ultragenyx
Rare mission. Fearless team. Incredible possibilities.
rare disease • ultra-rare disease
501 - 1000
Director, Biostatistics
July 24
🏡 Remote – New York
Ultragenyx
Rare mission. Fearless team. Incredible possibilities.
rare disease • ultra-rare disease
501 - 1000
Description
• 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.
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
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
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