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

Requirements:

* 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.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: hr@ultragenyx.com.

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