Sr Director, Biostatistics

Arbeitsbeschreibung

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

As a Sr Director, Biostatistics at Gilead you will ...

Reporting to the Head of Oncology Biostatistics, the Senior Director of Biostatistics will lead, manage, and develop a team of statisticians supporting late‑stage oncology development. This role provides strategic statistical leadership and oversight across development planning, regulatory interactions, and HTA/commercial evaluations for one or more Gilead oncology assets. The ideal candidate brings a strong track record of functional leadership, deep expertise in statistical methods for drug development, and demonstrated excellence in people leadership and talent development.

Job Responsibilities and Skills:

• Provide strategic statistical leadership for late-stage (Phase 3) oncology clinical trials, including design optimization and high-quality quantitative decision support.
• Serve as the Biostatistics statistical lead for assigned oncology molecules/indications, representing the function in Health Authority interactions and ensuring clear accountability and alignment with the Therapeutic Area Head.
• Partner cross-functionally with Statistical Programming, Clinical Research, Data Management, Clinical Operations, Global Drug Safety, Regulatory, and Project Management to deliver high-quality analyses and clinical reports on time and to standard.
• Apply statistical and regulatory principles to achieve scientific, regulatory, and business objectives; contribute to regulatory strategy and risk assessment; and support publications and external scientific presentations while proactively managing timelines and resources.
• Lead, mentor, and develop high-performing teams of experienced statisticians, including ownership of staffing strategy, succession planning, and long-term workforce planning.
• Leverage competitive intelligence and strong external scientific/regulatory networks (academia, industry, and Health Authorities) to inform development strategy, elevate scientific credibility, and enhance organizational visibility.

• Demonstrate strong judgment, decision-making, communication, and influencing skills, with the ability to drive alignment and execution across functions in complex, fast-paced, and ambiguous environments.
• Build effective partnerships within Biostatistics and across cross-functional stakeholders, fostering collaboration, shared accountability, and a culture of excellence.

Education and Experience:

• PhD with 12+ years or MS with 14+ years of biostatistics or statistical analysis experience in the pharmaceutical or biotechnology industry, including at least 5 years in oncology drug development.
• Strong hands‑on experience in oncology clinical development, including design and analysis of late‑stage (Phase 3) trials and leadership of NDA and/or BLA submissions.
• Demonstrated experience interacting with global Health Authorities and contributing to regulatory strategy and labeling discussions.
• Deep expertise in biostatistics, with proficiency in industry‑standard statistical software and application of current methodologies to improve study design, data quality, and decision making.
• Proven people‑management experience, including leading, mentoring, and developing teams of experienced statisticians.
• Solid understanding of the broader biopharmaceutical business, with recognized scientific or strategic credibility beyond Biostatistics.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.