Vice President, Biostatistics

Company: Ultragenyx Pharmaceuticals
Location: Novato
Posted on: January 14, 2021

Job Description:

Why Join Us?Be a hero for our rare disease patientsUltragenyx 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 Summaryultracurious --- Apply your biggest ideas in courageous waysThe Vice President 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. This position will also oversee and provide leadership to a team of 10 biostatisticians, 2 statistical consultants. The VP, Biostatistics will play a key role in the strategic planning for all clinical programs as well as the growth and development of this important segment of the company.Responsibilities including, but not limited to:The qualified candidate must have a minimum of 15 years of experience in applying statistics in a biopharmaceutical 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 inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators.The candidate must have experience within a team environment, and have good leadership and managerial skills, collaborative and negotiation skills and demonstrate self-motivation.Deep understanding of regulatory guidance and guidelines, as well as general knowledge of industry best practices and standards. Expert knowledge in Health Authority interactions and submission strategies.Prior experience with IND/BLA/NDA/MAA submissions.Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.Experience in writing technical and management documents, reports and presentations.Requirements:Ph.D. Applied Statistics, Statistics, or Biostatistics requiredLI-TR1Ultragenyx 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: (415) 483-8800 or by emailing us at talentacquisitionultragenyx.com. 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.See our Privacy Policy.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: talentacquisitionultragenyx.com.Brisbane, CA, Novato, CA, or Cambridge, MA /Ultragenyx --- Biometrics /VP

Keywords: Ultragenyx Pharmaceuticals, Novato , Vice President, Biostatistics, Executive , Novato, California