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Director, Biostatistics

AtaiBeckley, Inc.

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)
Vacancy posted 4 days ago
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