Senior Biostatistics Leader

13 hours ago


San Diego, California, United States Meet Full time
Meet Our Team

We are seeking a highly experienced Senior Director of Biostatistics to lead and shape the biostatistical strategy for clinical trials within our dynamic organization.

Key Responsibilities:
  • Develop and implement the statistical strategy for clinical trials, focusing on oncology and autoimmune indications.
  • Collaborate with cross-functional teams to ensure robust statistical planning, analysis, and reporting.
  • Oversee statistical contributions to study protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
  • Ensure compliance with regulatory guidelines and industry best practices in statistical methodologies.
  • Provide leadership and mentorship to biostatistics team members.
  • Contribute to regulatory submission processes, including interactions with the FDA and EMA.
  • Champion the use of innovative trial designs and statistical approaches in clinical development.
Key Qualifications:
  • Ph.D. or Master's in Biostatistics, Statistics, or a related field.
  • 5+ years of experience in biostatistics, with at least 5 years in a leadership role within the biotech or pharmaceutical industry.
  • Extensive experience in oncology and/or autoimmune disease therapeutic areas.
  • Proven expertise in statistical methods for clinical trials, including adaptive designs and Bayesian methods.
  • Strong understanding of regulatory requirements (FDA, EMA) and experience with submissions.
  • Excellent communication skills, with the ability to translate complex statistical concepts into actionable insights for cross-functional teams.
  • Passion for mentoring and developing biostatistics talent.


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