Executive Director, Biostatistics - Oncology

Executive Director, Biostatistics - Oncology
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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Job Description


Position Overview:

Reporting to the Head of Oncology Biometrics, the Executive Director of Biostatistics for Oncology will serve as the Franchise head for the areas of Hematology and GU/Gyn, as well as the head for Oncology Biometrics International, and oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions in these areas within Oncology Biometrics. 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. Biostatistics experience in international markets is preferred.

Key Responsibilities:

• Provides statistical oversight of all biostatisticians within the Hematology and GU/GYN areas and all biostatistics-related work conducted by internal biostatisticians and external consultants.
  
• Provides statistical oversight of all biostatisticians from Gilead's international sites and all biostatistics-related work conducted by internal biostatisticians and external consultants.
  
• Provides strategic inputs and statistical expertise for clinical development programs. Partners and collaborates with cross-functional Oncology leads to meet the regulatory, scientific and business objectives.
  
• Oversees and contributes to the completion of all technical and operational statistical activities through management of internal and external resources.
  
• Anticipates emerging projects 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.
  
• Ensures adherence to SOPs, BEDs, and all departmental 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.
  
• Responsible for ensuring scientific integrity of the statistical methodology applied to clinical trials. Accountable for ensuring rigorous statistical approaches implemented.
  
• Encourages and empowers biostatisticians to exercise good judgement, embrace data-driven approach, and follow the best practices and principles to become accountable decision-makers.
  

Minimum Requirements:

• PhD degree or MS degree in Biostatistics and 14+ years of Biostatistics pharma industry experience
  
• Oncology drug development experience is required, including the design and conduct of clinical studies from early through late-stage development and regulatory interactions.
  
• Proven effective verbal and written communication skills as well as negotiation and interpersonal skills
  
• In-depth knowledge of the drug development process as well as knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance
  
• Proven experience and ability to oversee people leaders. Ability to delegate, coach, and provide feedback and career development opportunities to team-members.
  
• Experience with providing 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.
  
• Proven sound 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, or solutions may produce unpleasant consequences in the short term.
  
• Prior experience with providing overall leadership for one or more departmental strategic initiatives. Ability to assess need 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. Drive change and influence decision making.
  
• Successful track record with advising and influencing senior leadership/functional leads on biostatistics strategies as well as functional issues that have a business impact. Experience with using competitive intelligence to influence clinical development strategies.
  

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