Senior Director Biostatistics - AI/ML

We have a current opportunity for a Senior Director Biostatistics - AI/ML on a permanent basis. The position will be based in New York. For further information about this position please apply.

Job Title: Senior Director, Biostatistics

Salary: $260-340,000 base salary + additional benefits

Location: New York | Boston, MA | RTP, North Carolina | San Francisco, CA |
Department: Clinical Development / Biometrics
Reports To: Vice President, Biometrics
Job Type: Full-Time

Position Summary:

We are seeking a strategic and innovative Senior Director of Biostatistics to lead our biostatistics function and provide expert statistical guidance across all phases of clinical development. This role will be instrumental in shaping statistical strategy, ensuring regulatory compliance, and driving data-driven decision-making to support our clinical programs.

Key Responsibilities:

• Strategic Leadership:

  • Lead statistical strategy and execution across clinical trials, ensuring alignment with corporate goals and regulatory expectations.
  • Collaborate cross-functionally to support clinical development plans, regulatory submissions, and scientific publications.
  • Represent Biostatistics in regulatory agency interactions and advisory meetings.

• Study Design & Execution:

  • Provide expert statistical input into clinical study design, endpoint selection, and analysis planning.
  • Explore and implement innovative trial designs (e.g., adaptive, Bayesian, platform trials) to optimize development strategies.
  • Ensure study designs are scientifically rigorous, operationally feasible, and aligned with regulatory expectations.
  • Leverage AI-driven clinical trial automation tools to enhance study execution, optimize resource allocation, and improve trial efficiency.

• Statistical Strategy & Innovation:

  • Drive statistical strategy across clinical development programs, incorporating optimal trial designs, simulation-based approaches, and AI/ML applications to enhance efficiency and decision-making.
  • Guide clinical and regulatory strategies to optimize trial design and maximize the probability of success.
  • Champion the use of advanced analytics and predictive modeling to support go/no-go decisions and portfolio prioritization.

• Operational Oversight:

  • Oversee the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
  • Ensure timely and high-quality statistical deliverables.
  • Manage internal teams and external vendors (e.g., CROs, consultants).

• Team Leadership:

  • Build and mentor a high-performing team of statisticians.
  • Foster a culture of innovation, collaboration, and continuous learning.

Qualifications:

• Ph.D. or M.S. in Biostatistics, Statistics, or a related field.
• 10+ years of experience in clinical biostatistics
• Demonstrated expertise in:
• • Designing and executing clinical trials across all phases.
  • Selecting appropriate endpoints and statistical methodologies.
  • Regulatory submissions and health authority interactions.
  • Simulation-based trial design and decision modeling.
  • AI/ML applications in clinical development and trial optimization.
• Strong understanding of ICH guidelines, GCP, and regulatory requirements (FDA, EMA, etc.).
• Proficiency in SAS, R (S-Plus), and statistical software for sample size calculations (e.g., East, PASS, NQuery). Expert R programming skills are a plus.
• Passion for innovation, AI-driven methodologies, and data-driven decision-making in clinical development.
• Proficiency in statistical software (e.g., SAS, R); experience with AI/ML platforms and tools is a plus.
• Excellent communication, leadership, and cross-functional collaboration skills.