Biostatistics Manager

Overview

With guidance, you will lead biostatistical analysis and reporting for a project or clinical study 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, you may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.

• With guidance, acts as biostatistics lead on clinical studies or other non-molecule projects.
• Where applicable and with guidance, leads statistical analysis of a project or study by collaborating with other Biostatistics team members and cross-functional partners.
• Provides statistical consultation on trial design and study endpoints, calculates sample size, and authors statistical analysis plans.
• Typically assigned clinical studies or other projects of moderate 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, 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.
• With guidance, 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.
• With guidance, 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, industry standards, and Gilead SOPs.

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

• PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment.
• MS in biostatistics or related discipline with 4+ years’ relevant experience in statistical analysis of biomedical data using SAS software.
• Where applicable, multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams, or…