Director of Biostatistics

11 - 15 years experience  • 

Salary depends on experience
Posted on 04/20/18
11 - 15 years experience
Salary depends on experience
Posted on 04/20/18

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.
Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.