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Solid Biosciences

Associate Director/Director, Biostatistics

303 - Clinical – Cambridge, Massachusetts
Department 303 - Clinical
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

Summary:

The Associate Director/Director will be responsible for leading all statistical activities pertaining to Solid’s clinical development programs including clinical trial design, interim analyses, and analysis and reporting of cumulative and final clinical trial data. The Associate Director/Director will oversee outsourced routine statistical and data management activities as well as drive more sophisticated aspects of statistical strategy for the advancement of Solid’s clinical programs. In addition, the Associate Director/Director may be called upon to provide statistical support to Solid’s non-clinical and translational projects as needed.  

Key Duties & Accountabilities:

  • Serve as in-house biostatistician for Solid’s clinical development programs
  • Manage outsourced biostatisticians/programmers/data managers
  • Perform trial statistician responsibilities including participation in study team meetings as needed, development of SAPs, reviewing shells and CRFs, design of early, mid and late-stage clinical trials, review of protocols/amendments, and conducting/supervising exploratory and ad hoc data analyses as appropriate
  • Apply innovative statistical approaches to study design, data analysis, and use of external data sources
  • Represent Solid/participate in collaborative external data-sharing consortia as needed
  • Help establish and maintain appropriate Solid data standards, data review/oversight practices, and related SOPs in alignment with contract research partners
  • Serve as a general clinical development and statistical resource
  • May perform additional duties and ad hoc projects as required 

Core Competencies Required:

  • Excellent oral and written communication, presentation, and teaching skills
  • Effective cross-functional collaborator
  • Leadership
  • Communication

Knowledge: Education, Experience, & Skills:

  • PhD in Biostatistics or related discipline with at least 5 years’ biopharmaceutical industry experience; MS in Biostatistics or related discipline with 8+ years’ biopharmaceutical experience may be considered
  • Experience with Bayesian methods and novel clinical trial designs preferred
  • Demonstrated expertise in biostatistics and its applications to clinical development
  • Adept in the use of current statistical software
  • Able to discuss and convey statistical concepts clearly to non-statistical colleagues
  • Innovative, open-minded, and nimble thinker
  • Able to work proactively and independently in a fast-paced, dynamic environment

Travel Commitment: 

  • Some travel may be required
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  • Location
    Cambridge, Massachusetts
  • Department
    303 - Clinical
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor
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