Director, Biostatistics

Director Of Biostatistics

AtaiBeckley is a clinical-stage biopharmaceutical company created through the strategic combination of atai Life Sciences and Beckley Psytech, forming a global leader in transformative mental health therapies.

We are on a mission to transform patient outcomes by developing effective, rapid-acting mental health treatments, supported by an industry-leading pipeline of psychedelic-based therapies.

Our people are at the heart of our progress: a diverse, highly skilled, and values-driven team located across Europe and the US, united by a shared commitment to reducing the global burden of mental health conditions.

If you are motivated by meaningful science, real-world impact and working with experienced, mission-driven colleagues, we'd love to hear from you.

The Director of Biostatistics supports the strategic design and execution of clinical trials in early- and late-stage programs spanning multiple therapeutic assets in neuropsychiatry. This fully remote role combines a hands-on role, to provide statistical leadership to matrixed global clinical study teams, with an oversight role over external vendors and CROs.

Key Accountabilities

• Statistical Leadership in Study Design (20%)
• Act as the primary statistical partner to study teams, leading the statistical analysis strategy and plan for clinical studies (Phase I–III), including endpoints, estimands, and sample size
• Effectively influence study design optimization and risk mitigation
• Contribute to protocol development and ensure alignment with regulatory expectations
• Advise study team on statistical considerations impacting study feasibility and interpretation

• Analysis Planning & Execution (25%)
• Development of Statistical Analysis Plans (SAPs), TFL shells, and data analysis specifications
• Ensure appropriate application and documentation of statistical methodologies
• Deliver high-quality data outputs to enable interpretation, decision-making, and regulatory submissions
• Support preparation of clinical study reports (CSRs) and submission documents
• Contribute to regulatory interactions, briefing documents, and responses to statistical queries leading to successful regulatory submissions

• Quantitative Decision Making and Strategic Insight (20%)
• Support interpretation of clinical trial data and program decisions with the study team and other stakeholders
• Drive the secondary analyses of completed trials to optimize description of value to stakeholders
• Provide quantitative insights of external trials to guide portfolio decision making

• Methodological Integrity and Documentation (20%)
• Work with Data Management to ensure data integrity, traceability, and reproducibility of statistical analyses
• Ensure analyses meet regulatory standards and withstand external scrutiny
• Maintain awareness of emerging statistical methodologies and regulatory guidance
• Contribute to internal standards, templates, and best practices

• Oversight of Statistical Programming & Vendors (15%)
• Oversee CROs and statistical programming teams to ensure quality, timelines, and compliance
• Review outputs (tables, listings, figures) and validate key analyses
• Drive consistency in statistical standards and processes across studies

Education, Experience and Skills necessary for the role

· Education

• MSc or PhD in Statistics, Biostatistics, or a related quantitative field

Experience

• Hands-on experience (typically 5-7+ years) in biostatistics within pharma, biotech, or CRO environments
• Significant experience designing and analyzing trials in neuropsychiatry, especially including CNS-related outcome scales strongly preferred
• Track record of supporting clinical trials across multiple phases strongly preferred
• Demonstrable successes in regulatory submissions and interactions
• Publications that illustrate an eye for effective scientific storytelling, and an ability to efficiently communicate quantitative data

Skills

• Ability to navigate a multidisciplinary matrix environment in drug development
• Verbal and written communication skills able to communicate complex statistical concepts clearly to diverse audiences
• High level of autonomy, accountability, and scientific rigor with ability to prioritize and navigate competing deadlines
• Mastery of statistical methodologies for clinical trials (e.g. survival analysis, longitudinal data, adaptive designs)
• Mastery of regulatory requirements (ICH, FDA, EMA)
• Mastery of statistical software (e.g. SAS, R) and clinical data standards (e.g. CDISC)