Senior Director, Biostatistics (Remote)

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Why Join Us?

Be a hero for our rare disease patients
 
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. 
 
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
 
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing.
 
US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
 
Roles based outside the US: If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.


Position Summary:

ultracurious – Apply your biggest ideas in courageous ways 

Reporting to the Head of Biostatistics, the Senior Director of Biostatistics acts as statistical lead with accountability for Ultragenyx Gene Therapy product and study deliverables; Provides strategic input in advancing clinical programs; Offers technical leadership and biostatistical support on the design and implementation of clinical studies; Leads regulatory interactions and submissions to the FDA and other regulatory agencies as biostatistics lead; Coordinates the effort across the different programs to identify, develop and implement departmental standards, applications, processes and training.
 
Work Model:
 
Remote: officially documented as working full time from home, with travel to Ultragenyx's offices or other location on occasion as needed

Responsibilities:

  • Contribute in study level tasks from statistics perspective, including but not limiting to: 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 TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings
  • Lead in product level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
  • Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
  • Translate statistical thinking into strategic input to advance the clinical program
  • Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
  • Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
  • Lead in developing department standards and research in advanced statistical methodologies
  • Author/review regulatory documents or scientific publications
  • Oversee work by CRO and ensure quality deliverables

Requirements:

  • PhD in Statistics or Biostatistics with a minimum of 13 years (minimum 15 years for master’s degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
  • Led in NDA/BLA/MAA activities from statistics perspective and experienced in direct regulatory interaction and experienced in regulatory inspections
  • Experienced as product lead statistician and contribute in strategy discussion in cross functional settings; Experienced in managing multiple products and studies and being able to prioritize; Prior experience in gene therapy is preferred
  • 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 (longitudinal data analyses, Bayesian method, CRM, adaptive design) is preferred
  • Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies

#LI-CS2
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#REMOTE

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

· Generous vacation time and public holidays observed by the company
· Volunteer days
· Long term incentive and Employee stock purchase plans or equivalent offerings
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· Professional development plans
 
* Benefits vary by region and country

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: (415) 483-8800 or by emailing us at [email protected]. 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[email protected].

More Information on Ultragenyx
Ultragenyx operates in the Biotech industry. The company is located in Novato, CA, Brisbane, CA, South San Francisco, CA, Miami, FL, Cambridge, MA, Waltham, MA, Woburn, MA and Miami, FL. Ultragenyx was founded in 2010. It has 1196 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Dental Benefits, Health Insurance Benefits, Life Insurance, 401(K) and Employee Stock Purchase Plan. To see all 6 open jobs at Ultragenyx, click here.
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