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