Executive Director, Biostatistics - Medical Affairs

Executive Director Of Biostatistics For Medical Affairs

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.

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Medical Affairs will lead the Biostatistics function for Medical Affairs studies across all therapeutic areas and will be responsible for building, scaling, and leading a high-performing Biostatistics team to support the Medical Affairs portfolio. The ideal candidate will have a proven track record of functional leadership, strategic situational judgment in using both innovative and pragmatic statistics, as well as demonstrated motivation for and excellence in people management and development.

Responsibilities

• Provides statistical oversight of all biostatisticians supporting Medical Affairs and all biostatistics-related work conducted by internal biostatisticians and external consultants.
• Provides strategic statistical input and expertise for Medical Affairs studies, observational studies, and broader evidence-generation activities across the portfolio, in partnership with relevant functions including RWE and HEOR.
• Oversees and contributes to the completion of all technical and operational statistical activities through management of internal and external resources.
• Builds, develops, and leads the Medical Affairs Biostatistics team, including team structure, staffing plans, capability development, and operating model.
• Anticipates emerging projects and works with senior management to develop staffing plans. Properly assigns and manages resources according to priorities and business strategies.
• Negotiates project timelines across programs with competing priorities given constraints. Manages and coordinates limited resources to produce quality deliverables within timelines.
• Develops and ensures adherence to SOPs, BEDs, and all departmental standards and processes regarding the conduct of Medical Affairs studies, 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.
• Ensures the scientific integrity of statistical methods applied to Medical Affairs studies and maintains rigorous statistical standards across the portfolio.
• Encourages and empowers biostatisticians to exercise good judgment, embrace a data-driven approach, and follow best practices and principles to become accountable decision-makers.
• Participates in relevant cross-functional leadership meetings, and represents the Biostatistics function.
• Provides clarity on expectations for biostatisticians supporting Medical Affairs, including delegation, decision-making, and communication framework. Provides constant constructive feedback accordingly.
• Develops talent action plans to ensure retention of top talent. Anticipates upcoming challenges, identifies potential capability gaps, and utilizes internal and external resources to bridge the gaps.
• Coordinates processes, training, and other managerial activities with Biometrics leadership. Assesses and addresses potential compliance risks and ensures audit and inspection readiness, as applicable.
• Expected to provide leadership support beyond the core Medical Affairs portfolio, including additional biostatistics and biometrics priorities as organizational and business needs evolve.

Capabilities and Skills:

• Excellent verbal and written communication skills. Excellent negotiation and interpersonal skills.
• In-depth knowledge of the drug development process, with strong commitment to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
• 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 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, or solutions may produce challenging short-term consequences.
• Ability to provide 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. Ability to drive change and influence decision making.
• Ability to advise and influence senior leadership and functional leads on biostatistics strategies as well as functional issues that have a business impact. Ability to use competitive intelligence to influence evidence-generation and development strategies.
• Experience in Medical Affairs, observational studies, and/or broader evidence-generation activities is preferred.

Basic Qualifications:

PhD and Twelve Years' Experience

Preferred Qualifications:

• PhD degree in Biostatistics or equivalent and minimum 16 years of industry experience is preferred.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem

The salary range for this position is: $302,005.00 - $390,830.00. 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*.

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