Executive Director, Biostatistics - Medical Affairs

Gilead Sciences•Parsippany, NJ

About The Position

The Executive Director of Biostatistics for Medical Affairs leads the Biostatistics function supporting Medical Affairs studies across all therapeutic areas. Reporting to the Head of Biometrics, this role builds, scales, and leads a high-performing team supporting the Medical Affairs portfolio. The position provides functional and strategic leadership, combining innovative and pragmatic statistical approaches with strong people management and development. It also provides leadership support beyond the core Medical Affairs portfolio as organizational and business needs evolve. The role oversees statistical work conducted by internal biostatisticians and external consultants, and provides strategic statistical expertise for Medical Affairs studies, observational studies, and broader evidence-generation activities in partnership with functions such as RWE and HEOR. It is accountable for technical and operational statistical activities, resource planning and allocation, quality and timeliness of deliverables, standards and processes, scientific integrity, and audit and inspection readiness. The Executive Director represents Biostatistics in cross-functional leadership settings and advises senior leaders on statistical strategies and business-impacting functional issues. The position requires a PhD and twelve years of experience. A PhD in Biostatistics or equivalent and at least 16 years of industry experience are preferred. Experience in Medical Affairs, observational studies, and/or broader evidence-generation activities is also preferred.

Requirements

PhD and twelve years of experience.
Excellent verbal and written communication skills.
Excellent negotiation and interpersonal skills.
In-depth knowledge of the drug development process and 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, provide feedback, and offer career development opportunities to team members.
Ability to establish a decision-making framework for team members that connects decisions and actions to future outcomes.
Excellent judgment and problem-solving skills in complex situations, including ability to identify the most important aspects of an issue.
Ability to make evidence-based decisions when information is limited or solutions may have challenging short-term consequences.
Ability to provide overall leadership for departmental strategic initiatives.
Ability to assess the need for process changes and recommend and implement infrastructure or processes that improve efficiency and quality.
Ability to integrate planning across departments to support organizational effectiveness.
Ability to drive change and influence decision-making.
Ability to advise and influence senior leadership and functional leads on biostatistics strategies and business-impacting functional issues.
Ability to use competitive intelligence to influence evidence-generation and development strategies.

Nice To Haves

PhD in Biostatistics or equivalent and a minimum of 16 years of industry experience.
Experience in Medical Affairs, observational studies, and/or broader evidence-generation activities.

Responsibilities

Provide statistical oversight of all biostatisticians supporting Medical Affairs and biostatistics-related work conducted by internal biostatisticians and external consultants.
Provide strategic statistical input and expertise for Medical Affairs studies, observational studies, and broader evidence-generation activities across the portfolio, partnering with functions including RWE and HEOR.
Oversee and contribute to technical and operational statistical activities through management of internal and external resources.
Build, develop, and lead the Medical Affairs Biostatistics team, including team structure, staffing plans, capability development, and operating model.
Anticipate emerging projects and work with senior management to develop staffing plans.
Assign and manage resources according to priorities and business strategies; negotiate timelines across programs and coordinate limited resources to deliver quality work on time.
Develop and ensure adherence to SOPs, BEDs, departmental standards, and processes for Medical Affairs studies, statistical methodology, data analysis, and interpretation.
Champion the development and training of decision-enabled statistical tools and explore more efficient and innovative statistical approaches.
Ensure the scientific integrity of statistical methods and maintain rigorous statistical standards across the portfolio.
Encourage biostatisticians to use sound judgment, data-driven approaches, and best practices, and to become accountable decision-makers.
Participate in cross-functional leadership meetings and represent the Biostatistics function.
Set clear expectations for delegation, decision-making, and communication; provide constructive feedback and develop talent action plans to retain top talent.
Anticipate challenges and capability gaps and use internal and external resources to address them.
Coordinate processes, training, and other managerial activities with Biometrics leadership.
Assess and address compliance risks and ensure audit and inspection readiness, as applicable.
Provide leadership support for additional biostatistics and biometrics priorities as organizational and business needs evolve.

Benefits

Discretionary annual bonus may be available.
Discretionary stock-based long-term incentives may be available; eligibility may vary by role.
Paid time off.
Company-sponsored medical insurance.
Company-sponsored dental insurance.
Company-sponsored vision insurance.
Company-sponsored life insurance.
Benefits are subject to the terms and conditions of applicable plans.

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