Senior Manager, Biostatistics

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

📋 Description

• Oversee biostatistical analysis and reporting, review documents, and ensure data inclusion for NDA submissions related to assigned studies.

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

• Calculate sample sizes and draft statistical analysis plans.

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

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

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

• Guide internal and external teams in statistical activities for molecules or marketed products.

• Take part in cross-functional planning for clinical development and protocol design and review.

• Advise partners on strategies for statistical analysis, measurement reliability, model identifiability, and interpretation of statistical outcomes.

• Collect, organize, and analyze data from various sources for special projects and assigned products.

• Review and analyze safety reports, biomarker analyses, and clinical trial monitoring data.

• Design, program, manage, and uphold complex statistical databases.

• Create enhancements to statistical software and stay informed about statistical methodologies and tools.

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

• Provide matrix management for supported projects and identify necessary resources.

• Comply with regulatory requirements, statistical analysis 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 experience in biomedical statistical analysis using SAS software, OR an MS with 6+ years of relevant experience, OR a BS with 8+ years of relevant experience.

• Relevant experience in biostatistics, including the effective leadership of small projects and project teams.

• Extensive experience in biomedical statistical analysis and proficiency with relevant software.

• Experience in developing software and tools that support statistical analysis of biomedical or related data.

• Strong proficiency in software and tools commonly used in 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.

• Strategic thinking in advising on statistical requirements and opportunities.

• Familiarity with drug development phases and associated clinical trials.

• Knowledge of FDA and EMA regulations, ICH guidelines, and GCP.

• Understanding of standard clinical procedures.

• Strong communication and organizational skills.

• Willingness to travel as necessary.

🏝️ Benefits

• Eligibility for discretionary annual bonuses.

• Eligibility for discretionary stock-based long-term incentives, which may vary based on role.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.

• Comprehensive benefits package.

• Reasonable accommodations available during the job application process.