Director Biostatistics

2 weeks ago

Boston, United States Aura BioSearch Full time

Director and Senior Director Biostatistics - Hybrid - Boston, MA.


About the Role - Serve as the biostatistics expert across clinical programs, providing strategic guidance across all phases


Responsibilities

  • Provide strategic guidance on optimizing trial designs for early-phase dose escalation and late-phase studies
  • Act as a biostatistics representative, coordinating with internal teams and external vendors to manage and execute statistical deliverables
  • Conduct statistical modelling to enable effective trial designs and address emerging statistical challenges
  • Contribute to protocol development, authoring or reviewing statistical sections, and ensuring alignment with statistical principles
  • Author or review statistical analysis plans for clinical trials, overseeing the development of tables, figures, and associated deliverables
  • Review electronic case report forms (eCRFs) to ensure compatibility with statistical analysis requirements
  • Offer statistical input for clinical documents and conduct QC/QA of statistical deliverables
  • Perform ad-hoc statistical analyses when necessary
  • Contribute to clinical study reports, including authoring statistical methods and interpreting study results
  • Lead statistical efforts supporting regulatory submissions, such as IND/NDA/MAA filings, ensuring thorough review of submission components and datasets
  • Address inquiries from regulatory bodies, such as the FDA or EMA, or other ethics committees
  • Support and contribute to the development of publications, including manuscripts, posters, and presentations
  • Lead standardization and process improvements within the Biostatistics team, including defining templates and setting standards
  • Represent the organization in discussions of statistical issues with external stakeholders, including regulatory bodies and partners
  • Participate in inspection readiness activities as required
  • Stay current in statistical methodologies and trial design practices, particularly in oncology-focused drug development


  • Required Skills, Experience and Education
  • PhD in statistics or a related discipline, or an MS with relevant experience
  • Minimum of 10 years of experience in the pharmaceutical or biotechsector
  • Required expertise in oncology
  • Proven track record in clinical trial design, analysis, and reporting
  • Experience with regulatory submissions (e.g., INDs, NDAs, MAAs)
  • Strong knowledge of clinical trial statistical methods and regulatory guidelines (FDA, EMA, ICH)
  • Proficiency in SAS and R for statistical programming
  • Experience in managing statistical aspects of multiple studies simultaneously
  • Familiarity with data standards (e.g., SDTM, ADaM)
  • Experience overseeing CRO-provided statistical services
  • Ability to work independently, address challenges proactively, and communicate statistical concepts effectively



Equal Opportunity Statement - We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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