Associate Director, Biostatistics

Gilead Sciences • Foster City, CA

66d • $195,670 - $253,220

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Requirements

• PhD with 6+ years of biostatistics experience is preferred.
• MS in biostatistics or related discipline with 8+ years of relevant experience in statistical analysis of biomedical data using SAS software.
• Minimum of 2 years of cross-functional project management or leadership experience in biostatistics or a related field in the biopharma industry.
• Significant biomedical statistical analysis experience and proficiency with relevant software and tools.
• Experience developing software and tools to support statistical analysis of biomedical or related data.
• Proven effectiveness in managing projects and teams.
• Advanced knowledge of biomedical statistical analysis, biostatistics best practices, and tools.
• Strategic thinking in advising on statistical requirements and opportunities to improve study or project outcomes.
• Understanding of drug development phases, clinical trials, FDA and EMA regulations, ICH guidelines, GCP, and standard clinical procedures.
• Strong communication and organizational skills.

Nice To Haves

• Ability to travel when needed.

Responsibilities

• Lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies.
• Collaborate with cross-functional partners to meet clinical development project deliverables and timelines.
• Provide statistical consultation on clinical development plans, clinical trial design and clinical study endpoints.
• Calculate sample size, author statistical analysis plans and provide biostatistical input into clinical development documentation.
• Contribute to short- and long-range Biostatistics strategies, plans and infrastructure development.
• Act as the biostatistics lead for clinical studies or non-molecule projects.
• Oversee and contribute to the completion of technical and operational statistical activities for groups of clinical trials.
• Participate in cross-functional clinical development planning and protocol design discussions.
• Advise partners on statistical analysis strategies and interpretation of statistical results.
• Lead the gathering, organization, and analysis of data sources for special projects.
• Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
• Use advanced statistical software, methods, and techniques to analyze and interpret research data.
• Plan and document computer data file structures and maintain complex statistical databases.
• Develop enhancements to statistical software and maintain knowledge of current statistical analysis methodologies.
• Participate in or lead special projects that benefit multiple team members.
• Provide matrix management to supported projects and define required resources for assigned work.
• Adhere to regulatory requirements, statistical analysis principles, industry standards, and company SOPs.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees