Associate Biostatistics Director

Associate Biostatistics Director

United States - California - Foster City Clinical Development & Clinical Operations Regular

The Associate Director, Biostatistics will lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross‑functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings.

Dependent upon the area of assignment, the position may lead projects or other activities that are non‑molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc. The Associate Director will also contribute to short‑and‑long‑range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics, such as team capability development.

• Acts as biostatistics lead on clinical studies or other non‑molecule projects.
• Where applicable, leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team members and cross‑functional partners.
• Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans.
• Typically assigned clinical studies or other projects of increasing complexity or size. Depending on area of assignment, may lead projects or other activities that are non‑molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.
• Where applicable, oversees and contributes to completion of all technical and operational statistical activities for a group of clinical trials.
• Directs internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products of increasing complexity.
• Where applicable, participates in cross‑functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical input.
• Where applicable, participates in cross‑functional protocol design and review discussions.
• Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Leads the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products.
• Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
• Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development.
• Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry.
• Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodologies and tools.
• Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
• May participate in or lead special projects that can benefit multiple Biostatistics team members, such as new methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation.
• Provides matrix management to projects supported.
• Independently defines required resources for assigned work, seeking advice as needed.
• Adheres to regulatory requirements of study conduct, statistical analysis principles,…