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Open nowFirst seen 5 days ago

Director/Sr Director Biostatistics

Aura BioSearch14 open roles

Where
Boston, Massachusetts, United States
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Your applicationOpen nowDirector/Sr Director BiostatisticsAura BioSearch · Boston, Massachusetts, United States

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: first seen 5 days ago

The posting

Director of Biostatistics

In this role, reporting to the Vice President of Biometrics, you will work with cross-functional clinical teams overseeing statistical activities across clinical programs, including managing statistical deliverables outsourced to CROs. This is an exciting opportunity to contribute to the development of transformative therapies.

Responsibilities:

  • Serve as a biostatistics expert for clinical programs.
  • Provide strategic input for trial designs in early-phase and late-phase studies.
  • Collaborate with internal and CRO team members to coordinate statistical deliverables.
  • Conduct statistical modeling for efficient study designs and address statistical issues.
  • Contribute to protocol development and author statistical analysis plans.
  • Review eCRF designs to ensure data collection meets analysis requirements.
  • Oversee QC/QA of statistical deliverables and perform ad hoc analyses as needed.
  • Support IND/NDA/MAA regulatory submissions and address queries from regulatory agencies.
  • Contribute to publications, including manuscripts and presentations.
  • Lead standardization and process improvement efforts for the Biostatistics function.

Requirements:

  • PhD in Statistics or related field, or MS with relevant experience.
  • 8+ years in the pharmaceutical or biotech industry.
  • Experience in clinical trial design, analysis, and reporting.
  • Proficient in statistical programming (SAS and R).
  • Familiarity with FDA, EMA, and ICH regulations.
  • Strong communication and collaborative skills.
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