About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered breakthroughs in treating some of the world's most devastating diseases, including HIV, viral hepatitis, COVID-19, and cancer. The company's relentless pursuit of innovation has delivered a cure for hepatitis C, revolutionary HIV treatments and prevention methods, and significant advancements in therapies for viral, inflammatory diseases, and certain cancers. Headquartered in the United States, Gilead operates globally, ensuring access to life-changing therapies across diverse populations. With a commitment to bold ambitions, collaboration, and scientific excellence, Gilead fosters an environment where every employee contributes to confronting major public health challenges and improving patient lives for generations.

Role Overview

The Senior Manager, Biostatistics-Oncology position at Gilead Sciences offers a pivotal leadership role within the company's cutting-edge oncology division. Reporting to senior biostatistics leadership, you will guide biostatistical strategies for clinical development projects, particularly in oncology. This role involves leading statistical analysis, reporting, and data management for New Drug Application (NDA) submissions, while collaborating with cross-functional teams to meet aggressive project timelines. Ideal for seasoned biostatisticians passionate about oncology research, this position supports Gilead's mission to advance therapies that transform cancer treatment, building on the company's storied success in HIV and inflammatory diseases.

Key Impact Areas

In this role, you will provide expert statistical consultation on clinical trial designs, endpoint selection, and sample size calculations. Your work will directly influence regulatory filings, scientific publications, and presentations that shape the future of oncology therapeutics at Gilead.

Key Responsibilities

As Senior Manager, Biostatistics-Oncology, your core duties include acting as the biostatistics lead on clinical studies or non-molecule projects, with guidance from senior leadership. You will spearhead statistical analysis, document review, and data inclusion for NDA submissions, partnering closely with Biostatistics team members and cross-functional stakeholders. Responsibilities encompass authoring statistical analysis plans, offering consultation on trial design and endpoints, and overseeing technical statistical activities for groups of clinical trials.

• Direct internal and external teams in executing statistical activities for oncology molecules or marketed products.
• Participate in cross-functional clinical development planning, providing biostatistical perspectives on protocols and strategies.
• Lead the gathering, organization, and analysis of diverse data sources for special projects and clinical study endpoints.
• Review safety reporting, biomarker analyses, and clinical trial monitoring aspects.
• Utilize advanced statistical software and methods to interpret research data, develop database structures, and enhance statistical tools.

These efforts ensure Gilead's oncology pipeline remains robust, innovative, and compliant with regulatory standards.

Qualifications & Requirements

To excel in this premium role, candidates must possess an advanced degree (Master's or PhD) in Biostatistics, Statistics, or a related field, coupled with substantial experience in the biopharmaceutical sector, particularly oncology clinical trials. Proficiency in statistical programming languages like SAS, R, or equivalent is essential, alongside deep knowledge of FDA regulatory processes for NDA submissions.

• Proven track record leading biostatistical efforts in complex clinical studies.
• Strong analytical skills for advanced statistical modeling, sample size determination, and data interpretation.
• Excellent communication abilities to collaborate with cross-functional teams, including clinical, regulatory, and medical affairs.
• Experience with biomarker analysis, safety reporting, and centralized statistical reporting preferred.
• Familiarity with emerging trends in biostatistical methodologies and tools.

Gilead values leaders who embody determination, inclusivity, and a drive to make a difference in patients' lives.

Benefits & Perks

Gilead Sciences prioritizes employee well-being with a comprehensive benefits package designed for holistic support. Enjoy competitive salaries benchmarked against industry leaders, performance-based bonuses, and equity opportunities. Health benefits include medical, dental, and vision coverage, plus wellness programs promoting physical and mental health. Financial perks feature 401(k) matching, retirement savings plans, and tuition reimbursement for ongoing professional development.

• Flexible work arrangements and generous paid time off.
• Employee stock purchase plans and financial planning services.
• Access to on-site fitness centers, childcare support, and volunteer opportunities.
• Global mobility programs for career advancement.

Career Growth

At Gilead, career progression is a cornerstone of the employee experience. As a people leader in this Senior Manager role, you will develop skills in team management, strategic planning, and innovation leadership. Gilead invests in talent through mentorship, leadership training, and exposure to high-impact projects across HIV, oncology, and inflammatory diseases. Many professionals advance to Director-level positions or pivot into broader R&D leadership, leveraging Gilead's global network for exponential growth.

Why Join Gilead

Joining Gilead means becoming part of a mission-driven team tackling humanity's biggest health challenges. Work on groundbreaking oncology therapies alongside experts who cured hepatitis C and revolutionized HIV care. Gilead's inclusive culture empowers every employee to thrive, with leaders fostering development and belonging. Contribute to scientific innovations that reach millions, supported by a collaborative environment and resources for bold ambitions. This is your chance to create possible, together, in a company where your impact echoes globally.

Role FAQs

Q: What experience level is required?
A: This role suits senior biostatisticians with 8+ years in pharma, ideally in oncology.

Q: Is travel involved?
A: Occasional travel for cross-functional meetings and conferences may be required.

Q: What software tools are used?
A: Primarily SAS, R, and other advanced statistical platforms.

Q: How does this role support Gilead's oncology pipeline?
A: By leading stats for trials advancing novel cancer therapies.

Q: What is the reporting structure?
A: Reports to Director or VP of Biostatistics, with matrixed cross-functional ties.