Director, Biostatistics

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)