Gilead Sciences · 2 weeks ago
Senior Manager, Biostatistics-Oncology
San Francisco Bay Area
Full-time
Onsite
Senior Level
$154K/yr - $199K/yr
6+ years expGilead Sciences is a biopharmaceutical company focused on creating a healthier world by tackling diseases like HIV and cancer. The Senior Manager, Biostatistics-Oncology will lead biostatistical analysis and reporting for clinical development projects, ensuring collaboration with cross-functional teams to meet deliverables and timelines.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
With guidance, acts as biostatistics lead on clinical studies or other non-molecule projects
Where applicable and with guidance, leads statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team members and cross-functional partners. Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing complexity or size. Depending on area of assignment, may lead projects or other activities that are non-molecule based, such as Biostatistics tools, programming, centralized analyses and reporting, etc
Where applicable, oversees and contributes to completion of 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 of increasing complexity
Where applicable, participates in cross-functional clinical development planning for one or more molecules or marketed products to provide the biostatistical perspective and biostatistical input
Where applicable, participates in cross-functional protocol design and review discussions
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
Leads the gathering, organization and analysis of different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products
Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring
Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development
Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry
Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodologies and tools
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 new methodologies, processes, technology and other tools, and may also participate in the development and / or implementation of SOPs and related documentation
Provides matrix management to projects supported
Independently defines required resources for assigned work, seeking advice as needed
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs
Qualification
Required
Bachelor's degree and 8 years of experience
Master's degree and 6 years of experience
PhD/ PharmD and 2 years of experience
Preferred
PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment. PhD with 4+ years' biostatistics experience is preferred
MS in biostatistics or related discipline with 6+ years' relevant experience in statistical analysis of biomedical data using SAS software
Multiple years' biostatistics or related experience, including experience effectively leading small projects and project teams
Significant biomedical statistical analysis experience and experience working with relevant software
Experience developing software and other tools to support statistical analysis of biomedical or related data. Strong proficiencies in software and other tools used typically used by Biostatistics
Proven effectiveness managing projects and teams
Demonstrated ability to be a fast learner
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
Has advanced knowledge of underlying statistical principles, concepts, practices, standards, processes and tools, and has shown ability to effectively apply this knowledge to achieve targeted outcomes to meet business needs
Has advanced knowledge of biostatistics best practices and tools and has shown ability to apply this to improve overall results
Demonstrates strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes
Understands drug development phases and the nature of associated clinical trials across phases
Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures
Strong communication and organizational skills
When needed, ability to travel
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-09
2026-01-08
2026-01-07
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