Senior Manager, Biostatistics

This is a fully remote position, open to applicants in California.

📋 Description

• Lead biostatistical analysis and reporting, conduct document reviews, and manage data inclusion for NDA submissions of assigned studies.

• Collaborate with cross-functional partners to achieve clinical development project goals and timelines.

• Offer statistical consultation on clinical development strategies, clinical trial design, and clinical study endpoints.

• Calculate sample sizes and write statistical analysis plans.

• Contribute biostatistical insights into clinical development documentation, scientific publications, presentations, and regulatory submissions.

• Serve as the biostatistics lead on clinical studies or non-molecule projects.

• Supervise and engage in technical and operational statistical tasks for clinical trials.

• Guide internal and external teams in defining, executing, and completing statistical activities.

• Participate in cross-functional planning and design/review of clinical development protocols.

• Advise collaborators on statistical analysis strategies, measurement reliability, model identifiability, and the interpretation and presentation of findings.

• Collect, organize, and analyze various data sources for special projects, statistical analysis plans, and clinical study endpoints.

• Review and evaluate safety reporting, biomarker analyses, and clinical trial monitoring data.

• Utilize advanced statistical software, methodologies, and techniques to analyze and interpret research data.

• Plan and document computer data file structures; develop, program, manage, and maintain complex statistical databases.

• Enhance statistical software by programming new techniques.

• Engage in or lead special projects involving methodologies, processes, technology, tools, SOPs, and related documentation.

• Provide matrix management to supported projects.

• Define necessary resources for assigned tasks and comply with regulatory requirements, statistical principles, industry standards, and Gilead SOPs.

• Foster inclusion, develop talent, and empower teams as a people leader.

⛳️ Requirements

• PhD in biostatistics or a related field with a minimum of 2+ years of relevant biomedical statistical analysis experience using SAS software, or an MS with 6+ years, or a BS with 8+ years.

• Relevant experience in the statistical analysis of biomedical data utilizing SAS software.

• Experience in biostatistics or a related field effectively leading small projects and project teams.

• Extensive biomedical statistical analysis experience and familiarity with relevant software.

• Experience in developing software and tools to facilitate statistical analysis of biomedical or related data.

• Strong proficiency in software and tools commonly used within Biostatistics.

• Proven capability in managing projects and teams effectively.

• Advanced knowledge of statistical principles, concepts, practices, standards, processes, and tools.

• In-depth understanding of biostatistics best practices and tools.

• Knowledge of drug development phases and the associated clinical trials.

• Familiarity with FDA and EMA regulations, ICH guidelines, and GCP.

• Understanding of standard clinical procedures.

• Strong communication and organizational abilities.

• Willingness to travel as necessary.

🏝️ Benefits

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives (eligibility may vary based on role).

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.

• Reasonable accommodation in the job application process.