Director, Biostatistics

Why Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. Position Summary:ultracurious – Apply your biggest ideas in courageous waysThe 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 perspectiveContribute 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 meetingsWorks collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reportingEnsure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirementsIndependently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study resultsContribute to developing standards and research in advanced statistical methodologiesAuthor/review regulatory documents or scientific publicationsMentor junior team membersRequirements: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 industryExperienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interactionExperienced as product lead statistician and contributing to strategy discussion in cross functional settings; Experienced in managing multiple products and studies and being able to prioritizeExperienced in study level work including authoring SAP and TFL specificationFamiliar with ICH guideline, FDA / EMA / other regulatory authority guidanceSolid understanding of mathematical and statistical principles; Experience in statistical methods analyzing longitudinal data is preferredDetailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timelineFamiliar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologiesThe typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in thi