Duties: Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy; Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols; Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents; Presents summary data and analyses results, in a clear, concise, complete, and transparent manner; Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information
Requirements: PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience; Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation; Great interpersonal, communication, writing and organizational skills; Expertise in statistical/clinical trials methodology as it related to clinical development and ability to apply to relevant clinical development framework

Duties: Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contributes to project development strategy; Defends protocols and analysis plans at internal governance reviews and provides independent reviews of complex protocols; Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents; Presents summary data and analyses results, in a clear, concise, complete, and transparent manner
Requirements: PhD (6+ years’ experience) or MS (8+ years’ experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience; Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation

Duties: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices; Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards; Leads/Supports the electronic submission preparation and review; Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
Requirements: Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required; At least 7 years programming experience in industry including support of significant regulatory filings; For US positions: US military experience will be considered towards industry experience; Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data

Duties: The Associate Director of Biostatistics is a member of cross-functional development teams supporting neuroscience therapeutic area, and contributes to trial design, protocol development, analysis, planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, the Associate Director of Biostatistics can have responsibilities for supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the Biostatistics indication/asset Lead, and other cross functional team members
Requirements: PhD in Biostatistics