Senior Manager, Biostatistics-Oncology

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At Gilead, we’re creating a healthier world for all people by developing therapies for diseases such as HIV, viral hepatitis, COVID‑19 and cancer. We are looking for passionate and ambitious people ready to make a direct impact on life‑changing scientific innovations.

With guidance, you will lead biostatistical analysis, reporting, document review, and data inclusion for NDA submissions of assigned studies, collaborating with cross‑functional partners to meet clinical development project deliverables and timelines. You may also lead projects or other activities that are non‑molecule based, such as Biostatistics tools, programming, centralized analyses, and reporting.

• Act as biostatistics lead on clinical studies or other non‑molecule projects.
• Lead statistical analysis, document review, and data inclusion for NDA submissions, providing statistical consultation on trial design, study endpoints, and authoring statistical analysis plans.
• Oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials.
• Participate in cross‑functional clinical development planning and protocol design discussions.
• Advise partners on statistical analysis strategies, reliability of measurements, model identifiability, and interpretation of results.
• Gather, organize, and analyze data from different sources for special projects and the statistical analysis plan.
• Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
• Use advanced statistical software and techniques to derive useful information for clinical development.
• Plan and document computer data file structure; develop, program, manage, and maintain complex statistical databases.
• Develop enhancements to statistical software, maintaining knowledge of current and emerging trends.
• Provide biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory filings.
• Lead matrix management for supported projects and define required resources.
• Adhere to regulatory requirements, statistical analysis principles, industry standards, and Gilead SOPs.

• Bachelor’s degree and 8 years of experience.
• Master’s degree and 6 years of experience.
• PhD/Pharm
  
  D and 2 years of experience.

• PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software; 4+ years biostatistics experience preferred.
• MS in biostatistics or related discipline with 6+ years of relevant experience.
• Multiple years of biostatistics experience, including leading small projects and project teams.
• Significant biomedical statistical analysis experience and software development for statistical tools.
• Strong proficiency in software and tools used by Biostatistics.
• Proven project and team management effectiveness.
• Fast learner, flexible, and adaptable to change.
• Advanced knowledge of statistical principles, best practices, and tools.
• Strategic thinking in advising on statistical requirements and opportunities for improvement.
• Understanding of drug development phases across all phases.
• Knowledge of FDA, EMA regulations, ICH guidelines, GCP, and standard clinical procedures.
• Strong communication and organizational skills.
• When needed, ability to travel.

• Create Inclusion by embedding diversity value in team management.
• Develop Talent by coaching employees on performance and potential.
• Empower Teams by aligning goals and removing barriers.

Other US Locations: $ – $.

Bay Area: $ – $.

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. Eligible employees may also receive discretionary annual bonus, stock‑based long‑term incentives, paid time off, and a benefits package that includes company‑sponsored medical, dental, vision, and life insurance plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, fostering an inclusive work environment. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity, veteran status, or other prohibited grounds. Applicants requiring accommodation may contact Appli