Gilead Sciences

Manager

• Acts as biostatistics lead on clinical studies or other non-molecule projects
• 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
• May lead projects or activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting
• 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
• Participates in cross-functional clinical development planning and protocol design to provide biostatistical input
• Advises internal and external partners on choice of statistical analysis strategies, reliability of measurements, identifiability of models, and interpretation and presentation of statistical results
• Leads gathering, organization and analysis of different data sources to enable delivery of special projects and statistical analysis plans
• 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
• 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 by programming new techniques; maintains knowledge of current and emerging trends
• Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation
• Participates in or leads special projects (methodologies, processes, technology, SOP development) that benefit multiple Biostatistics team members
• Provides matrix management to projects supported and defines required resources for assigned work
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Senior Manager, Biostatistics

Director

• Design, develop, and implement statistical workflows and solutions supporting drug development with scalable, reproducible R-based tools
• Oversee version control and collaborative coding on GitHub, ensuring quality and CI/CD integration
• Partner with stakeholders to align data infrastructures and maintain governance and compliance
• Lead complex R package initiatives, ensuring timely delivery, testing, and documentation
• Define data workflow architectures integrating R packages into enterprise pipelines and cloud components
• Champion open-source best practices within regulated pharmaceutical context

Associate Director, Biostatistics

Risk

• Lead Subject Matter Expert and Process Owner for RBQM areas, processes, and technologies.
• Lead collaborations with CRO partners to ensure continuous improvement and alignment with Gilead’s RBQM framework, including representing RBQM in governance committees.
• Provide oversight of vendors performing RBQM activities, ensuring effective, high quality, and timely delivery of portfolio requirements.
• Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM.
• Study Risk Assessment and Mitigations
• Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes.
• Advise study teams throughout risk management activities, fostering cross-functional collaboration, and promoting excellence in risk management.
• Contribute to the development of new central monitoring tools to address risks and support study oversight, Contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, performance indicators, and develop the study’s Central Monitoring plan.
• Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan.
• Facilitate cross-functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues.
• Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.
• Operational Excellence
• Lead the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training materials to support operational efficiency and scalability.
• Manage RACT libraries, driving consistency across programs and therapeutic areas.
• Lead or actively contribute to cross-functional committees, projects and workstreams focused on continuous improvement and innovation.
• Develop and analyze RBQM performance metrics to assess compliance, effectiveness, and areas for optimization.
• Serve as a champion for change initiatives by fostering an innovative mindset, bridging RBQM knowledge across functions, and promoting new ideas, best practices, and modern ways of working.
• Build and maintain strong partnerships with service providers, influencing strategic relationships and ensuring high-quality deliverables.
• Represent Gilead in industry-wide collaborations, contributing thought leadership and sharing best practices.
• Stay current with RBQM-related regulations, trends, and industry standards to continuously improve the RBQM framework, processes, technologies, oversight, and compliance.

Director, Risk Based Quality Management

• Serves as a project lead to provide oversight on multiple outsourced aggregated product level safety analyses projects.
• Acts as a fluent programmer in sophisticated Clinical Safety Surveillance analyses projects.
• Independently identifies issues in the analysis and assures project quality consistency.
• Acts as a stakeholder in multi-functional discussion on project scope, milestone, and project timeline negotiation.
• Lead programmer for multiple projects; may serve as project leader; overseeing vendor project activities and deliverables.
• Generates or oversees the production of statistical output for aggregated compound level safety projects.
• Actively share experiences and discuss possible process enhancements at programming meetings; recommends potential trainings.
• Ensures programming and documentation is completed in a manner that is consistent with departmental procedures; must lead and manage multiple concurrent projects.
• Knowledge of CDISC Standards (SDTM and ADaM) is a plus.
• Understands KPI/KQI, data harmonization, and analysis dataset creation for safety deliverables.

Senior Manager, Biostatistics

Associate Director, Biostatistics

Director, Risk Based Quality Management

Manager, Statistical Programming