Associate Director, Biostatistics

Ultragenyx Pharmaceuticals Novato, CA
* 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

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

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