Senior Manager, Biostatistics

About the role

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 ensure access to these therapies across the globe. As a Senior Manager, Biostatistics, you will lead biostatistical analysis and reporting, document review, and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines.

This role may include providing statistical consultation on clinical development plans, clinical trial design, clinical study endpoints, calculating sample size, authoring statistical analysis plans, and providing biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory filings. Depending on the area of assignment, you may lead non-molecule-based projects such as Biostatistics tools, programming, centralized analyses, and reporting.

Responsibilities

• Act as biostatistics lead on clinical studies or other non-molecule projects with guidance.
• Lead statistical analysis, document review, and data inclusion for NDA submissions of assigned studies by collaborating with Biostatistics team members and cross-functional partners.
• Provide statistical consultation on trial design, study endpoints, and author statistical analysis plans.
• Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials.
• Direct internal and external teams in defining, executing, and completing statistical activities for one or more molecules or marketed products.
• Participate in cross-functional clinical development planning to provide biostatistical perspective and input.
• Advise internal and external partners on statistical analysis strategies, reliability of measurements, and interpretation of statistical results.
• Lead the gathering, organization, and analysis of data sources to enable delivery of special projects, statistical analysis plans, and clinical study endpoints.
• Review and analyze safety reporting, biomarker analyses, and other aspects of clinical trial monitoring.
• Use advanced statistical software, methods, and techniques to gather, analyze, and interpret research data for clinical development.
• Plan and document computer data file structure; develop, program, manage, and maintain complex statistical databases; perform or supervise data entry.
• Develop enhancements to statistical software by programming new techniques and maintain knowledge of current trends in statistical methodologies and tools.
• Provide biostatistical input into clinical development documentation, scientific publications, presentations, and regulatory documentation.
• Participate in or lead special projects benefiting multiple Biostatistics team members, such as new methodologies, processes, technology, and tools.
• Provide matrix management to supported projects and independently define required resources for assigned work.
• Adhere to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.

Requirements

• PhD in biostatistics or related discipline with at least 2+ years of relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia, or a related environment, OR
• MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software, OR
• BS in biostatistics or related discipline with 8+ years’ relevant experience in statistical analysis of biomedical data using SAS software.
• 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 proficiency in software and tools typically used by Biostatistics.
• Proven effectiveness managing projects and teams.

Preferred Qualifications

• PhD with 4+ years’ biostatistics experience.
• Demonstrated ability to be a fast learner and adaptable to change.
• Advanced knowledge of underlying statistical principles, concepts, practices, standards, processes, and tools.
• Advanced knowledge of biostatistics best practices and tools.
• Strategic thinking in advising others on statistical requirements and opportunities to improve study or project outcomes.
• Understanding of 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.
• Ability to travel when needed.

People Leader Accountabilities

• Create Inclusion: Model inclusion and embed the value of diversity in team management.
• Develop Talent: Understand skills, experience, aspirations, and potential of employees; coach them on current performance and future potential.
• Empower Teams: Align team goals and purpose with organizational objectives, provide support to remove barriers, and connect the team to the broader ecosystem.

Pay

The salary range for this position is $153,935.00 - $199,210.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit Gilead Compensation, Benefits, and Wellbeing.