Executive Director, Biostatistics

Novato, CA or Brisbane, CA
Ultragenyx – Biometrics
Full-time
Why Join Us?
Be a hero for our rare disease patients
 
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, 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 no approved therapies.     
 
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!

The Executive Director or Vice President of Biostatistics is responsible for the statistical aspects of clinical trials, including experimental design, statistical analysis, and reporting.  This experienced, progressive biostatistician will work collaboratively with clinicians, data managers, biostatisticians, and statistical programmers in the planning and analysis of clinical studies. They will also oversee and provide quality control to a team of 7, statistical consultants, and will be responsible for the strategy and growth of the biostatistics department.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS:

    • The qualified candidate must have a minimum of 15+ years of experience in applying statistics in a pharmaceutical or related industry.
    • The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, analysis of clinical imaging results such as echocardiograms, SAS programming, and other relevant software applications, statistical methodologies, theories and analysis including adaptive designs and Bayesian analysis.
    • Demonstrated expertise in Rare Disease global clinical development (preferred)
    • The preferred candidate will have a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.
    • Excellent written and communication skills with the ability to influence widely and work collaboratively with clinical project teams and senior management are required.
    • The candidate must have experience within a team environment, and have good leadership and managerial skills,   collaborative and negotiation skills and demonstrate self-motivation.
    • Prior experience interacting with health authorities in the United States and/or the EU.
    • Prior experience with IND/BLA/NDA/MAA submissions.
    • Excellent computer skills in the following programs:  MS Word, PowerPoint, and Excel.
    • Experience writing technical and management documents, reports and presentations.

EDUCATION:

    • Ph.D. or MS in Statistics, Biostatistics or equivalent required
Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit 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 totalentacquisition@ultragenyx.com.