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Gilead Sciences, Inc. VP, Oncology Biometrics in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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Job Description

Vice President, Head of Oncology Biometrics

Reporting to the SVP Clinical Data Science, the Head of Oncology Biometrics will lead the combined Oncology Statistical Programming and Biostatistics teams, partnering closely with her/his clinical leadership peers to develop the strategy and execute on all early- to late-stage trial activities supporting Gilead’s rapidly growing Oncology portfolio. In this capacity, the individual will oversee Biometrics workstreams for Oncology development programs, clinical trials, assets evaluations, and regulatory submissions. This individual will also be responsible for recruiting, resourcing, and building Biometrics capabilities to support the expanding Oncology portfolio.

In 2020, Gilead made the strategic decision to co-locate the quantitative sciences supporting its clinical pipeline within the Clinical Data Science organization. This structure allows for rapid decision-making and the agile coordination across quantitative disciplines to support the diverse evidence needs throughout the lifecycle of our medicines. As a member of the Clinical Data Science Leadership Team, the Head of Oncology Biometrics will partner closely with his/her quantitative peers to design and execute on an integrated evidence strategy supporting the entire Oncology product lifecycle, from early biomarker discovery/development, PK/PD through phases 1- 3, regulatory approval, medical affairs, and market access.

This role is an influential leader within the company, championing appropriate methodological approaches and study designs, driving the institution of best practices on the planning, execution, and interpretation of our clinical studies, while also encouraging the rigorous development and assessment of novel methodologies, technologies, and datasets with the potential to improve the drug development process.

The ideal candidate will have a proven track record of functional leadership, strategic situational judgement in using both innovative and pragmatic statistics, as well as demonstrated motivation for and excellence in people management and development. The ideal candidate will also have a proven track record of leading Oncology Biometrics team through multiple submissions and approvals.

Core Responsibilities:

  • Strategic Thinking: Understands competitor landscape and relevant global trends in Oncology. Anticipates emerging issues relevant to Oncology portfolio. Identifies Biometrics strategic needs and provides the Biometrics’ perspective to inform the Oncology TA strategy in development. Proactively identifies opportunities to accelerate our Oncology portfolio through collaboration with her/his Clinical Data Science peers

  • Influence and Partnership: Establishes productive collaborations and strategic partnerships with cross-functional leaders in the Oncology Therapeutic Area. Communicates with clarity and influences regulators and key stakeholders. Establishes external relationships with academic and industry experts to stay abreast of advanced analytics and statistical methodology

  • Innovation: Stays current with the latest industry trend and development in Oncology Biometrics. Identifies opportunities for innovative trial designs and advanced analytics when appropriate. Leverages both internal and external innovators to develop the best solutions

  • Delivery Excellence: Builds and develops an expert team of statistical programmers and biostatistics researchers to execute on Gilead’s oncology pipeline; Leads an assessment of Gilead’s current biometrics capabilities and strengths and develops a roadmap for building additional capabilities where needed; Ensures the execution and integrity of protocols, statistical analysis plans, study reports and presentations and publications of studies by applying your past experiences and providing leadership

Additional Responsibilities:

  • People Development: Develops others by identifying and mentoring high performers and building a culture of inclusion and collaboration throughout the organization; Delegates responsibility and empowers others.

  • Decision-making: Maintains a culture of rigorous data-driven decision making that rewards truth-seeking behavior; Encourages employees to exercise good judgement and embrace decision making; Empowers capable individuals to be accountable decision-makers

  • Communication: Represents and champions the entire Clinical Data Sciences organizations across all areas of the business; Creates excitement and passion for the role of Biometrics to inform strategy and decisions across the organization

Capabilities & Requirements:

  • Provides oversight of all biostatisticians and statistical programmers in the TA and all biometrics-related work conducted by internal and external resources for the TA

  • Provides strategic inputs and statistical expertise for clinical development programs. Partners and collaborates with cross-functional TA leads to meet the regulatory, scientific and business objectives

  • Oversees and contributes to the completion of all technical and operational biometrics activities in the TA through management of internal and external resources

  • Anticipates emerging projects in the TA and works with senior management to develop staffing plan. Properly assigns and manages resource according to priorities and development strategies

  • Negotiates project timelines across programs with competing priorities given constraints. Manages and coordinates limited resources to produce quality deliverables within timelines

  • Works in partnership with peer Biometrics TA leaders and organizations to establish and ensure adherence to cross-TA biostatistics and statistical programming best practices, SOPs, BEDS, standards, and processes regarding the conduct of clinical trials, statistical methodology, data analysis and interpretation

  • Champions the development and training of decision-enabled statistical tools. Explores opportunities for more efficient and innovative statistical approaches

  • Encourages and empowers biostatisticians to exercise good judgement, embrace data-driven approach, and follow the best practices and principles to become accountable decision-makers

  • Responsible for ensuring scientific integrity of the statistical methodology applied to clinical trials. Accountable for ensuring rigorous statistical approaches implemented in the TA

  • Excellent verbal and written communication skills. Excellent negotiation and interpersonal skills

  • In depth knowledge of the drug development process. In depth knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance

  • Proven ability to supervise team leads who supervise personnel. Ability to delegate, coach, and provide feedback and career development opportunities to team-members

  • Ability to provide team-members with a framework for decision-making that delineates the actions associated with the decisions made under the framework and recognizes that appropriate actions taken in the present impact the chance of positive outcomes in the future

  • Excellent judgment and problem-solving skills in complex situations. Ability to identify the most important aspects of an issue. Ability to make effective evidence-based decisions even when information is limited

  • Ability to provide overall leadership for one or more departmental strategic initiatives. Ability to assess needs for changing processes, and to recommend and implement new infrastructure and/or processes to improve efficiency and quality

  • Ability to integrate planning efforts across departments to ensure organizational effectiveness. Ability to drive change and influence decision making

  • Ability to advise and influence senior management and functional leads on Biostatistics strategies as well as functional issues that have a business impact. Ability to use competitive intelligence to influence clinical development strategies

Education & Qualifications:

  • PhD in Biostatistics, Statistics or related field

  • 15+ years of experience working in a Biotech/Pharma R&D business function, including 10+ years in Oncology TA, preferably with experience in both hematology and solid tumors

  • 3+ years of experience managing a biometrics function of 20+ combined biostatisticians and statistical programmers, including team leads who supervise biostatisticians

  • Experience of successfully leading Oncology biometrics teams from early through late-stage development and regulatory interactions, including hands-on experience of leading late stage programs from pivotal study designs through submissions and approvals

  • Extensive knowledge of clinical trial design, statistical methodology, and regulatory guidance. Experience of driving strategic planning and implementing innovative statistical designs across the development portfolio

Gilead Core Values

  • Integrity (Doing What’s Right)

  • Inclusion (Encouraging Diversity)

  • Teamwork (Working Together)

  • Excellence (Being Your Best)

  • Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 for assistance.

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 for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.