Our client, a clinical-stage biopharmaceutical company pioneering cell therapy for autoimmune diseases and cancer immunotherapy, seeks an experienced Senior Director, Biostatistics. This role will establish and lead the Biostatistics function, driving the statistical strategy and execution of innovative clinical programs.

Key Responsibilities

• Leadership: Build and standardize biostatistics practices, aligning with clinical and regulatory goals.
• Statistical Analysis: Hands-on design and execution of statistical analyses, including TFL generation and advanced methods (e.g., adaptive Bayesian designs).
• Clinical Studies Management: Oversee global clinical trial design, monitoring, and analysis in collaboration with CROs.
• Regulatory Support: Lead statistical aspects of regulatory submissions and agency interactions.
• Cross-Functional Collaboration: Partner with clinical, medical, regulatory, and safety teams to ensure efficient trial execution.

Qualifications

• Education: Ph.D. in Biostatistics, Statistics, or related field.
• Experience:
• 8+ years in biostatistics for clinical trials, with expertise in immunology or oncology and regulatory interactions.
• Proven success in designing complex trials and driving regulatory approvals.
• Technical Skills: Proficiency in R and SAS; experience with CDISC standards and TFL generation.
• Other Skills: Strong communication, attention to detail, and ability to thrive in fast-paced, cross-functional environments.