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Director, Biostatistics

Company: Ultragenyx Pharmaceutical Inc.
Location: Novato
Posted on: July 21, 2020

Job Description:

Why Join Us? Be a hero for our rare disease patients Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission to make a difference in our patients lives. Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding. Position_Summary ultradedicated Your biggest challenges yield rare possibilities The Director, Biostatistics acts as a statistical lead for a Clinical and Medical affairs projects. He/she provides technical leadership and biostatistical support on the design and conduct of clinical and post approval studies. The Director will lead regulatory interactions and submissions to the FDA and other regulatory agencies. They will provide strategic input in advancing the clinical program. They participate in the evaluation, interpretation, and reporting of study results. The Director performs statistical analyses and develops tracking systems for data quality assurance. He/she provides timely support to the project teams on all statistical matters according to the project strategies. The Director is responsible for addressing all administrative functions required for project management and milestones. The Director identifies and communicates changes in project requirements that may affect key deliverables at the project level. Responsibilities,_Including_But_Not_Limited_To o Lead in product level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective o 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 o Works collaboratively within biometrics teams and with cross- functional teams to meet product deliverables and timelines for statistical data analysis and reporting o Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements o Independently conduct analyses suggested by the data; Propose new/ novel statistical methodological approaches to improve the efficiency and sensitivity of study results o Translate statistical thinking into strategic input to advance the clinical program o Author/review regulatory documents or scientific publications o Oversee statistical consultants or junior team members Requirements o PhD in Statistics or Biostatistics with a minimum of 10 years of post-graduate experience in the clinical trials setting in the pharmaceutical industry o Led in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct regulatory interaction o Experienced in regulatory inspection o Experienced as product/study lead statistician and contribute in strategy discussion in cross functional settings; Experienced in leading multiple studies and being able to prioritize o Experienced in study level work including authoring SAP and TFL specification, and data base integration such as ISS and ISE o Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance o Solid understanding of mathematical and statistical principles; Experience in statistical methods analyzing longitudinal data is preferred o Excellent communication and interpersonal skills, with the ability to translate statistical concept to program strategies o Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according company timeline and corporate goals o Familiar with SAS; 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. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: or by emailing us at . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. See our CCPA Employee and Applicant Privacy Notice . 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: . Show moreShow less

Keywords: Ultragenyx Pharmaceutical Inc., Novato , Director, Biostatistics, Executive , Novato, California

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