Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

We are seeking a highly motivated individual to join us as a Senior Manager, Biostatistics. You will work with the Biostatistics team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Associate Director, Biostatistics.

The Senior Manager, Biostatistics will be responsible for all statistical aspects within a clinical development program, including statistical input into the clinical development plan, support of translational research, design and analysis of clinical trials, interaction with regulatory authorities and key opinion leaders, and management and oversight of outsourcing partners, with a particular emphasis on safety reporting and pharmacovigilance. The manager, Biostatistics will be accountable for the validity and quality of all statistical input and deliverables for the assigned projects. Additionally, the manager, Biostatistics will provide consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality.

Responsibilities (include but are not limited to):

• Provides statistical expertise and input to drug development programs and safety surveillance including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value.
• Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
• Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Authors technical reports and publications, ensures the timely delivery of top line study results.
• Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses.
• Ability and experience to work with safety to develop appropriate tools and analysis strategies for safety surveillance
• Monitors project progress and ensures proper resource allocation; performs vendor oversight for assigned programs and provides quality review of vendor deliverables.
• Establishes and maintains effective working relationships with vendors and project teams.
• Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in oncology; maintains currency with developments in these fields.
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.

Basic Qualifications:

• BS in biostatistics, statistics, or mathematics and 8+ years of experience in biostatistics in clinical development and drug development experience - OR -
• MS in biostatistics, statistics, or mathematics and 6+ years of experience in biostatistics in clinical development and drug development experience – OR -
• PhD in biostatistics, statistics, or mathematics and >1+ years of experience in biostatistics in clinical development and drug development experience

Preferred Qualifications:

• PhD or MS in biostatistics, statistics, or mathematics highly preferred
• Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development
• Excellent verbal, written, and presentation skills including the ability to clearly describe advanced statistical techniques and interpret results
• Working knowledge of SAS and/or R

The salary range for this position is: $146,200.00 - $189,200.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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