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

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 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 defining, executing, and completing statistical activities • Participate in cross-functional clinical development planning, protocol design, and review discussions • 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 other clinical trial monitoring data • 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 and define required resources • Ensure adherence 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 experience in biomedical statistical analysis using SAS software • OR MS in biostatistics or related discipline with 6+ years of relevant experience using SAS software • OR BS in biostatistics or related discipline with 8+ years of relevant experience using SAS software • Biostatistics or related 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 • Understanding of drug development phases and clinical trials across phases • 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 • Demonstrated ability to learn quickly, adapt to change, move between projects, and provide support or expertise where 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 • Reasonable accommodation in the job application process