Executive Director, Head of Biometrics, Infectious Disease

AstraZeneca • Gaithersburg, MD

17h • Hybrid

About The Position

The Infectious Disease unit was created to optimize AstraZeneca's portfolio of vaccines and antibodies for infectious diseases. We are committed to developing and implementing scientific advancements that build pandemic preparedness, protect against future health crises, and bring lasting immunity to people around the globe. As Head of Biometrics for Infectious Disease, you will have a unique opportunity to further elevate the Infectious Disease Therapy Area in one of the world's most respected biopharmaceutical companies. You will be a core member of the Late Infectious Disease Development Leadership Team, leading the global capability for biostatistics, statistical programming, and associated disciplines supporting the ID pipeline.

Requirements

• PhD in Biostatistics, Applied Mathematics, Statistics, or other relevant quantitative discipline (MSc considered with exceptional experience), with a minimum of 5 years of pharmaceutical/life sciences industry experience.
• Demonstrated expertise in multiple statistical modalities across Phase I–IV clinical trials, with a comprehensive understanding of the R&D drug development lifecycle.
• Substantial experience providing statistical and programming support to clinical development projects via direct report or matrix structure—including delivery of multiple complex, large studies (e.g., pivotal Phase 3 efficacy studies) in parallel.
• Experience with innovative statistical methods and fluency in regulatory language associated with statistical analysis plans.
• Experience with global regulatory submissions and interactions with major Health Authorities.
• Understanding of regulatory guidelines pertaining to data handling, integrity, and industry data standards (e.g., CDISC).
• Leadership/participation in cross-industry statistical subject-knowledge groups, with a demonstrable network of external experts.
• Proven ability to drive strategy in a pharmaceutical development environment, working collaboratively with cross-functional stakeholders at all levels.
• Demonstrated ability to lead, coach, mentor, and motivate high-performing teams in a global matrix environment.
• Demonstrated ability to cultivate excellent partnerships and resolve conflicts across a broad stakeholder base.
• Excellent communication skills with the ability to present data, strategy, and innovation to upper management and in public venues.
• Demonstrated experience applying AI-enabled and generative AI tools to support clinical development activities (e.g., data analysis, medical writing, clinical trial operational efficiency).
• Positive change-management skills and pedigree, with resilience and the ability to motivate others in a dynamic environment.
• Must demonstrate high integrity and independence.
• Willingness and ability to travel domestically and internationally.

Nice To Haves

• Experience presenting to FDA Advisory Committees is a plus.
• Experience with medicine or vaccine development in infectious diseases.
• Significant and consistent peer-reviewed publication track record.
• Experience with externalization models and managing outsourcing collaborations.

Responsibilities

• Serve as the overall accountable leader for the strategy and execution of quantitative analytics across all Clinical Development Programs (CDPs) within the Infectious Disease Therapeutic Area.
• Push the boundaries of modern statistical methods—including innovative trial design, digital sensor data analysis, and AI-enabled approaches—through collaboration, publication, and scientific exchange with external academic and industry groups.
• Attract, retain, and develop a high-performing, cross-skilled team of statisticians, programmers, and associated disciplines, creating a stimulating environment that allows team members to grow their careers in multiple directions.
• Maintain a wide set of collaborative relationships with academics, KOLs, regulators, and cross-industry groups to enhance AstraZeneca's external standing and bring new ideas in-house.
• Lead and develop a cross-skilled team of statisticians, programmers, and other relevant disciplines—including individual contributors and team leaders—within a matrix environment. Ensure resource and expertise are appropriately deployed for maximal impact across multiple programmes.
• Drive programmes to maintain a high-quality, cutting-edge skills base aligned to R&D needs through permanent recruitment, outsourcing alliances, academic collaborations, graduate recruitment, internships, and secondments.
• Ensure appropriate statistical designs, data collection and analysis tools, and processes to clearly and robustly address the objectives of clinical studies and programmes.
• Provide oversight for the quality and timeliness of clinical development planning, study design, analysis, and reporting—including contributions to study protocols, statistical analysis plans, clinical study reports, and regulatory activities.
• Influence decision-making for early/late clinical development plans, decision criteria, proof-of-concept study design, and in-licensing opportunities—specifically accountable for quantifying uncertainty at investment decisions.
• Establish mechanisms for review of emerging real-time data during clinical trials and advances in statistical methodology for payer/reimbursement applications.
• Represent the Biometrics function on the Late ID Development Leadership Team, contributing to strategy, vision, and objectives.
• Establish dynamic collaboration with other relevant groups to ensure smooth transition of clinical projects through each clinical phase.
• Collaborate with Biometrics Therapy Area Leaders and Clinical Teams to ensure statistical innovation across all development phases.
• Proactively direct strategic cross-R&D collaborations and represent AstraZeneca on internal/external panels, boards, and other bodies as required.
• Lead statistical contributions to global regulatory submissions and interactions with major Health Authorities (FDA, EMA, and others).
• Ensure a judicious review of innovative proposals so that the benefit/risk equation is well understood.
• Provide internal and external scientific, technological, and computational expertise to enhance evidence-based and data-driven clinical decision-making across R&D.

Benefits

• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health, dental, and vision coverage
• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles

What This Job Offers

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