Associate Director, Biostatistics
Why Join Us?
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco. This position can be located in Novato or Brisbane.
- Acts as indication / 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
- Lead regulatory responses and submissions to the FDA and other regulatory agencies
- Performs statistical analyses and develops tracking systems for data quality assurance
- Provides timely support to the project teams on all statistical matters according to the project strategies
- Report to the Head of Biostatistics
Responsibilities, including but not limited to:
- 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 in study level tasks from statistics perspective, including: Contribute in study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TLG shell and specification Review CRFs and other study documentations; Active participation in study related meetings
- Work 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 in developing department standards and research in advanced statistical methodologies
- Author/review regulatory documents or scientific publications
- Mentor junior team members
- PhD in Statistics or Biostatistics with a minimum of 8 years (minimum 11 years for master) 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 indication lead statistician and contribute in strategy discussion in cross functional settings; Experienced in managing multiple projects 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
- Excellent communication and interpersonal skills, with the ability to translate statistical concept into operational strategies
- Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according company timeline
- Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies