Astrix-posted 7 months ago
$220,000 - $240,000/Yr
Full-time • Senior
Cambridge, MA
Professional, Scientific, and Technical Services

Our client is a clinical-stage biotechnology company pioneering therapies to address severe genetic diseases. They are currently seeking a Director of Biostatistics—a collaborative, open-minded leader with strong interpersonal skills and a passion for teamwork—to join their dynamic and mission-driven team. The Director of Biostatistics will lead statistical strategy across all clinical development phases. This role is key in guiding trial design, data analysis, and regulatory submissions, while managing CROs and collaborating across internal teams.

  • Develop and execute statistical plans supporting clinical trials and regulatory filings
  • Design and review protocols, SAPs, and clinical study reports
  • Analyze trial data and present findings to technical and non-technical audiences
  • Represent Biostatistics in regulatory interactions (FDA, EMA)
  • Oversee CROs to ensure high-quality deliverables
  • Collaborate with Clinical Development, Data Management, and Medical Writing
  • Monitor industry trends and regulatory changes
  • Support SOP development and departmental budgeting
  • Ph.D. or Master's in (Bio)Statistics with 10+ years in pharma/biotech
  • Deep knowledge of global regulatory guidelines and CDISC standards
  • Experience across Phases 1-3 and NDA submissions
  • Strong vendor/CRO management skills
  • Skilled in SAS and R; excellent communication and leadership abilities
  • Familiar with GCP, SOPs, and clinical compliance standards
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