Senior Biostatistics Lead – Virology Programs

Gilead Sciences, Inc (Gileadhotjobcareers); Foster City (CA); On-site; USD 196,000 - 253,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical, dental, vision, and life ins.

Job summary

Gilead Sciences, Inc. in the San Francisco Bay Area seeks an Associate Director of Biostatistics to provide strategic and operational statistical leadership for Virology clinical programs.

You will represent Biostatistics on study and development teams, collaborating with Clinical Development, Regulatory Affairs, and Programming to ensure high-quality planning, analysis and reporting. The role involves designing studies, determining sample sizes, SAPs, TFLs and CSR reviews, and leading

Qualifications

• Bachelor's Degree with 10 years of experience.
• Master's Degree with 8 years of experience.
• PhD with 2 years of experience.

Responsibilities

• Serve as lead statistician for Phase 1–3 trials with responsibility for overall statistical strategy and delivery.
• Acts as biostatistics lead on clinical studies or other non-molecule projects.
• Represent Biostats on study management teams and development teams, providing strategic statistical leadership, and collaborate closely with other Biostatistics team members and cross-functional team.
• Provides statistical consultation on trial design, endpoints, analysis methods, and authors statistical analysis plans
• Overseas and lead all technical and operational statistical activities for a group of clinical trials. Directs internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products.
• Contribute strategic statistical leadership to cross-functional clinical development planning and protocol development.
• Where applicable, advises internal and external partners as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
• Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring to inform development decisions
• Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret historical and external data to derive useful information for clinical development.
• Provides biostatistical input into clinical development documentation, scientific publications and presentations and regulatory documentation.
• May participate in or lead special projects that can benefit multiple Biostatistics team members, such as innovative methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation.
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Skills

Biostatistics leadership

Clinical trial statistics

Statistical analysis

Regulatory knowledge

Education

Bachelor's Degree

Master's Degree

PhD

Tools

SAS

R

Python

Job description

Gilead Sciences, Inc. in the San Francisco Bay Area seeks an Associate Director of Biostatistics to provide strategic and operational statistical leadership for Virology clinical programs.

You will represent Biostatistics on study and development teams, collaborating with Clinical Development, Regulatory Affairs, and Programming to ensure high-quality planning, analysis and reporting. The role involves designing studies, determining sample sizes, SAPs, TFLs and CSR reviews, and leading