Associate Director, Biostatistics - Gene Therapy
Ultragenyx - Gene Therapy – Biometrics
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.
With the company’s recent acquisition of Dimension Therapeutics, the Ultragenyx Gene Therapy division was established. The Ultragenyx Gene Therapy division is headquartered in Cambridge, 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!
ultraimpact – Make a difference for those who need it most
Acts as indication / program statistical lead
Provides technical leadership and biostatistical support on the design and conduct of clinical studies
Participates in the evaluation, interpretation, and reporting of study results
Lead regulatory responses and submissions to the FDA and other regulatory agencies
Performs statistical analyses and develops tracking systems for data quality assurance
Provides timely support to the project teams on all statistical matters according to the project strategies
Report to the Director of Biostatistics
Responsibilities, including but not limited to:
- Lead in product / indication level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
- Contribute in study level tasks from statistics perspective, including: 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 TLG shell and specification Review CRFs and other study documentations; Active participation in study related meetings
- Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
- Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
- Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
- Contribute in developing department standards and research in advanced statistical methodologies
- Author/review regulatory documents or scientific publications
- Mentor junior team members
Technical Skills & Requirements:
- PhD in Statistics or Biostatistics with a minimum of 5-8 years of post-graduate experience in the pharmaceutical industry
- Experience in the development of statistical plans, programming, and analyses of Phase I-IV clinical trials
- Experience in Rare Disease is a plus
- Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction
- Experienced as indication lead statistician and contribute in strategy discussion in cross functional settings; Experienced in managing multiple projects and being able to prioritize
- 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 analyzing longitudinal data is preferred
- Excellent communication and interpersonal skills, with the ability to translate statistical concept into operational 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 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 to: firstname.lastname@example.org.