Director, Biostatistics

Role Summary

Director or Senior Director of Biostatistics who will have a pivotal role in shaping the design, analysis, and interpretation of clinical trial data for our precision neuromedicine programs. Reporting to the VP of Biometrics, you will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process.

Responsibilities

• Contribute to the design of clinical trials, including writing or reviewing statistical sections of protocols and statistical analysis plans (SAPs).
• Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards.
• Support the generation of tables, listings, and figures (TLFs) and contribute to the interpretation of results.
• Collaborate with Clinical and Regulatory teams to provide statistical input to study reports, regulatory submissions, and publications.
• Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
• Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
• Assist in the development, validation, and documentation of statistical methodologies and processes.
• Oversee and manage external CROs and vendors to ensure high-quality and timely deliverables.
• Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making.
• Ensure all statistical activities comply with regulatory guidelines and company policies.
• Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDAs).
• Contribute to development of internal statistical processes, SOPs, and initiatives.

Qualifications

• PhD with 10+ years of experience (12+ for Senior Director) OR MS with 12+ years of experience (15+ for Senior Director) in statistics, biostatistics, or a closely related discipline within the pharmaceutical or bio-tech sector.
• CNS therapeutic area experience is a plus
• Skilled in scientific programming including SAS or R, or Python for data analysis, graphing, and simulation
• Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH)
• Extensive knowledge with CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting
• Ability to communicate complex statistical concepts clearly to non-statistical audiences.
• Strong attention to detail, organizational skills, and ability to manage multiple projects in a fast-paced environment.
• Proven collaboration, leadership, and organizational skills
• Significant experience with global regulatory agency interactions
• Experience in resource planning, recruiting, and defining organizational needs with senior leaders