Senior Manager, Biostatistics

Job not on LinkedIn

🔥 47 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $169.3k - $219.1k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $3.5M Post-IPO Debt - Gilead Sciences on 2024-11

Healthcare • Biotechnology • Pharmaceuticals

Gilead Sciences is a global biopharmaceutical company focused on researching, developing, and commercializing medicines primarily in virology, oncology, and inflammation. The company advances transformative therapies, runs extensive clinical programs and research collaborations, and supports access, global health, and community funding initiatives. Gilead also emphasizes corporate responsibility, sustainability, and inclusion while maintaining a broad pipeline of therapies and patient access programs.

📋 Description

• Lead biostatistical analysis and reporting, document review, and data inclusion for NDA submissions of assigned studies • Collaborate with cross-functional partners to meet clinical development project deliverables and timelines • Provide statistical consultation on clinical development plans, clinical trial design, and clinical study endpoints • Calculate sample sizes and author statistical analysis plans • Provide biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory filings • Act as biostatistics lead on clinical studies or non-molecule projects • Oversee and contribute to technical and operational statistical activities for clinical trials • Direct internal and external teams in defining, executing, and completing statistical activities • Participate in cross-functional clinical development planning and protocol design and review • Advise partners on statistical analysis strategies, measurement reliability, model identifiability, and interpretation and presentation of results • Gather, organize, and analyze different data sources for special projects, statistical analysis plans, and clinical study endpoints • Review and analyze safety reporting, biomarker analyses, and clinical trial monitoring data • Use advanced statistical software, methods, and techniques to analyze and interpret research data • Plan and document computer data file structures; develop, program, manage, and maintain complex statistical databases • Develop enhancements to statistical software by programming new techniques • Participate in or lead special projects involving methodologies, processes, technology, tools, SOPs, and related documentation • Provide matrix management to supported projects • Define required resources for assigned work and adhere to regulatory requirements, statistical principles, industry standards, and Gilead SOPs • Create inclusion, develop talent, and empower teams as a people leader

🎯 Requirements

• PhD in biostatistics or related discipline with at least 2+ years of relevant biomedical statistical analysis experience using SAS software, or MS with 6+ years, or BS with 8+ years • Relevant experience in statistical analysis of biomedical data using SAS software • Biostatistics or related experience effectively leading small projects and project teams • Significant biomedical statistical analysis experience and experience with relevant software • Experience developing software and tools to support statistical analysis of biomedical or related data • Strong proficiency in software and tools typically used by Biostatistics • Proven effectiveness managing projects and teams • Advanced knowledge of statistical principles, concepts, practices, standards, processes, and tools • Advanced knowledge of biostatistics best practices and tools • Understanding of drug development phases and associated clinical trials • Knowledge of FDA and EMA regulations, ICH guidelines, and GCP • Familiarity with standard clinical procedures • Strong communication and organizational skills • Ability to travel when needed

🏖️ 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