Director/Senior Director of Biostatistics

2 months ago


San Diego, United States Meet Full time

We are seeking an experienced Senior Director of Biostatistics to lead and shape the biostatistical strategy for clinical trials within this dynamic organization. You will play a critical role in overseeing statistical design, data analysis, and regulatory submissions, working closely with cross-functional teams in clinical development, data management, and regulatory affairs. As a senior leader, you will also mentor junior staff and drive innovations in trial design and statistical methodologies.


Key Responsibilities:

  • Lead the statistical strategy for clinical trials, from Phase I through Phase III, primarily focusing on oncology and autoimmune indications.
  • Collaborate with clinical, regulatory, and medical affairs 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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