Executive Director, Biostatistics - Medical Affairs

Gilead Sciences • Parsippany, NJ

3d • $274,550 - $355,300

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 serving the Medical Affairs portfolio. The position provides strategic statistical leadership for Medical Affairs studies, observational studies, and broader evidence-generation activities, while ensuring scientific integrity, rigorous standards, and high-quality delivery.

The role oversees statistical work performed by internal biostatisticians and external consultants; manages resources, priorities, and timelines; and establishes team structure, staffing plans, capabilities, operating models, standards, and processes. It represents Biostatistics in cross-functional leadership forums, advises senior leaders on statistical strategies and business-impacting functional issues, and supports organizational priorities beyond the core Medical Affairs portfolio as needs evolve.

The Executive Director is also responsible for people leadership, including coaching and developing team members and team leads, providing clear expectations and constructive feedback, supporting talent retention, and identifying capability gaps. The role coordinates managerial activities with Biometrics leadership and helps address compliance risks and maintain audit and inspection readiness.

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.
• 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 support team members’ career development.
• Ability to establish decision-making frameworks that clarify appropriate actions and account for the impact of present decisions on future outcomes.
• Excellent judgment and problem-solving skills in complex situations, including identifying key issues and making evidence-based decisions when information is limited.
• Ability to provide overall leadership for departmental strategic initiatives and assess, recommend, and implement process or infrastructure changes.
• Ability to integrate planning across departments, drive change, and influence decision-making.
• Ability to advise and influence senior leadership and functional leads on biostatistics strategy and functional issues with business impact.
• Ability to use competitive intelligence to influence evidence-generation and development strategies.

Nice To Haves

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

Responsibilities

• Provide statistical oversight of biostatisticians supporting Medical Affairs and biostatistics work performed by internal staff and external consultants.
• Provide strategic statistical input for Medical Affairs studies, observational studies, and broader evidence-generation activities in partnership with functions such as 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 develop staffing plans with senior management; assign and manage resources according to priorities and business strategies.
• Negotiate timelines across programs with competing priorities 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 efficient, innovative statistical approaches.
• Ensure scientific integrity and rigorous statistical standards across Medical Affairs studies and the portfolio.
• Empower biostatisticians to exercise sound judgment, use data-driven approaches, and follow best practices and principles.
• Participate in cross-functional leadership meetings and represent the Biostatistics function.
• Clarify expectations, delegation, decision-making, and communication frameworks for biostatisticians supporting Medical Affairs, and provide constructive feedback.
• Develop talent action plans to retain top talent, anticipate challenges, identify capability gaps, and use internal and external resources to address them.
• Coordinate processes, training, and managerial activities with Biometrics leadership; assess compliance risks and support audit and inspection readiness as applicable.
• Provide leadership support beyond the core Medical Affairs portfolio as organizational and business needs evolve.
• Lead departmental strategic initiatives, recommend and implement processes or infrastructure to improve efficiency and quality, and influence organizational decision-making.
• Advise and influence senior leadership and functional leads on biostatistics strategy and business-impacting functional issues.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree