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Senior Director, Biostatistics

Company: Lever
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Why Join Us? Be a hero for our rare disease patients Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target 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. Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy. Senior Director, Biostatistics

Cambridge, MA /

Ultragenyx - Gene Therapy - Biometrics /

Full-time

Apply for this job

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target 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.

Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.

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 remote based web-ex video discussions, interviews & onboarding.

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.

Responsibilities including, but not limited to:

* 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

* Excellent communication and interpersonal skills, with the ability to translate statistical concept to program strategies

* Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according company timeline

* Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies

#LI-TR1

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 talentacquisition@ultragenyx.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: talentacquisition@ultragenyx.com.

Apply for this job * 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 * Excellent communication and interpersonal skills, with the ability to translate statistical concept to program strategies * Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according company timeline * Familiar with SAS and R; 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: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.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: talentacquisition@ultragenyx.com.

Keywords: Lever, Cambridge , Senior Director, Biostatistics, Other , Cambridge, Massachusetts

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