- Full Time
- United States

Mantell Associates
Mantell Associates are thrilled to have partnered with a leading Biotech company who are seeking a Senior Director of Biostatistics (AI/ML) to join their team in advancing the clinical development of rare disease treatments.
Senior Director of Biostatistics (AI/ML) – Responsibilities:
- Lead the strategy and application of AI/ML methods to biostatistical analysis in clinical trials for rare diseases.
- Develop and implement innovative statistical models using machine learning and AI techniques to address unique challenges in rare disease clinical trials.
- Oversee the design of clinical trials and statistical analysis plans incorporating AI/ML approaches for more efficient and insightful data analysis.
- Collaborate with data science, clinical operations, regulatory affairs, and other teams to ensure AI/ML strategies are aligned with therapeutic goals and regulatory standards.
- Interpret and communicate AI/ML-driven findings to senior leadership, clinical development teams, and regulatory agencies, ensuring clarity and understanding of complex results.
- Stay at the forefront of AI/ML advancements and their application in biostatistics, continuously evolving approaches for rare disease clinical trials.
- Lead the biostatistics team in integrating AI/ML tools with traditional statistical methods for comprehensive analysis and reporting.
- Mentor and provide strategic leadership to a team of biostatisticians and data scientists, ensuring high-performance and professional growth.
Senior Director of Biostatistics (AI/ML) – Requirements:
- PhD in Biostatistics, Statistics, Data Science, or a related field, with a strong background in AI/ML techniques.
- Minimum of 10 years of experience in biostatistics, with at least 5 years in a leadership role focused on AI/ML applications in clinical research.
- Expertise in applying machine learning, deep learning, and other AI methodologies in clinical trial analysis, preferably in rare diseases or complex therapeutic areas.
- Strong experience in statistical software (e.g., R, Python, SAS) and machine learning frameworks (e.g., TensorFlow, PyTorch, scikit-learn).
- In-depth knowledge of regulatory requirements and experience with FDA/EMA submissions involving AI/ML methodologies.
- Excellent communication skills, with the ability to explain complex AI/ML concepts to both technical and non-technical stakeholders, and to lead strategic discussions.
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.
Tagged as: Analytical, Management, programming