Director of Biostatistics

Ultragenyx Pharmaceutical   •  

Cambridge, MA

11 - 15 years

Posted 237 days ago

This job is no longer available.

Position Summary

Reporting to the Head of Biostatistics, the 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 thedesign and implementation of clinical studies; Leads regulatory interactions and submissions to the FDA andother regulatory agencies as biostatistics lead; Coordinates the effort across the different programs to identify, develop and implement departmental standards, applications, processes and training.    

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 10 years (minimum 13 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.