Senior Manager, Biostatistics

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $153.9k - $199.2k / 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 • 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 statistical activities for molecules or marketed products • Participate in cross-functional clinical development planning and protocol design and review • Advise partners on statistical analysis strategies, measurement reliability, model identifiability, and interpretation of statistical results • Gather, organize, and analyze data from different sources for special projects and assigned products • Review and analyze safety reporting, biomarker analyses, and clinical trial monitoring data • Develop, program, manage, and maintain complex statistical databases • Develop enhancements to statistical software and maintain knowledge of statistical methodologies and tools • Participate in or lead special projects, methodologies, processes, technology, tools, SOPs, and related documentation • Provide matrix management to supported projects and define required resources • Adhere to regulatory requirements, statistical analysis 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 experience in biomedical statistical analysis using SAS software, OR MS with 6+ years of relevant experience, OR BS with 8+ years of relevant experience • Relevant biostatistics experience, including effectively leading small projects and project teams • Significant biomedical statistical analysis experience and experience with relevant software • Experience developing software and tools supporting 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 • Strategic thinking in advising on statistical requirements and opportunities • 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 eligibility • 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 • Benefits package • Reasonable accommodation in the job application process