Statistical Science Director Infectious Disease

AstraZeneca; Durham (NC); On-site; USD 180,000 - 280,000; Full time

Job summary

AstraZeneca is seeking a Statistical Science Director to lead statistical strategies across development plans, regulatory strategy, and commercial presentations. You will guide design, analysis, and interpretation for governance committees and regulatory submissions, while mentoring staff and advancing methodological innovations.

You will collaborate with cross-functional teams, partner with CROs, and represent statistical strategy in governance forums.

Qualifications

• Advanced degree in statistics or mathematics with a strong statistical component.
• At least 5 years of experience in clinical trials; leadership required.
• Proven independent leadership and cross-functional influence.
• Strong communication and collaboration across teams and regulators.

Responsibilities

• Lead statistical design and strategy for product development plans and regulatory strategies.
• Ensure quality of study designs, documents, delivery, interpretation, and submission.
• Quantify benefit, risk, value, and uncertainty of product profiles and communicate within teams.
• Provide global leadership and direct work by internal and external staff; partner with CROs.

Skills

Independent leadership

Statistical expertise

Cross-functional collaboration

Excellent communication

Mentoring staff

Regulatory knowledge

Education

MSc/PhD in Statistics/ Mathematics with substantial statistics

Tools

SAS

R

Python

Job description

Are you ready to lead and innovate in the world of clinical statistics? As a Statistical Science Director at AstraZeneca, you'll leverage your extensive experience in the pharmaceutical industry to independently guide statistical strategies and technical activities. Whether it's designing, delivering, or interpreting data for high-level governance committees or regulatory submissions, your expertise will be pivotal. You'll also have the opportunity to be recognized externally as a methodology expert, leading technical analyses and mentoring less experienced staff. Join us and collaborate across functions to make a real impact!

What You’ll Do

In this role you will be responsible in leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team. You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile. You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of statistics staff in the technical arena.

The Accountabilities For Supporting Projects Directly Include

• Lead the statistical design and strategy to product development plans, preclinical studies, regulatory strategy, health technology assessment, and/or commercial activities as appropriate for the stage of the product.
• Lead the statistical content and ensure quality for study designs, documents, delivery, interpretation, and submission.
• Quantify the benefit, risk, value, and uncertainty of the emerging product profile and communicate these effectively within the team.
• Provide global leadership to others and direct project work delivered by internal and external staff.
• Partner with CROs to ensure delivery to quality and time.
• Represent AstraZeneca externally which may include health authorities, advisory boards, conferences, workshops, and/or payer interactions.
• Maintain knowledge of statistical methodology in relevant areas and promote, investigate, and implement novel statistical approaches.
• Represent statistical strategy and decision-making at internal governance including review boards, therapy area leadership teams, and ESPC/LSPC.
• Mentor/coach and support the technical education and training of Statistics staff.

The accountabilities for supporting statistical methodological advances are (technical focus):

• In-depth knowledge of technical/regulatory requirements with experience in pharma/healthcare.
• Stay up-to-date and implement novel statistical approaches.
• Experience with and broad awareness of regulatory interactions and/or submissions.
• Excellent communication skills/build strong relationships.
• Nationally recognized externally. Invited to attend or speak at seminars and external meetings. Well-rounded statistician with publications on a range of topic areas. Publications resulting from external collaborations.
• Expert Leadership role able to lead/direct work across a team.

What we’re looking for:

This role requires an individual with outstanding technical skills, leadership, and the ability to guide and support multiple studies while fostering team development and project success.

Essential Skills/Experience

• MSc/PhD in Statistics, Mathematics (with a substantial statistical component), or a recognized equivalent to a stats MSc.
• Proven track record of independent leadership.
• 5 years of experience in clinical trials is critical for this role.
• Recognized for exemplary technical skills and expert leadership role or national recognition as a statistical technical expert.
• Demonstrated ability to provide cross-study support, overseeing, aligning, and providing technical support for multiple studies.

Desirable Skills/Experience

• Experience in Vaccines & Immunotherapy is a strong asset but open to other therapeutic areas (TA).
• Implemented simulation programming for sample size calculations or interim analyses.
• Experience with business development opportunities, such as in-licensing, would be beneficial.
• Proficiency in programming languages such as SAS, R, and Python.
• Strong project management skills.
• Excellent communication skills, especially in relation to project management, ensuring effective cross-functional collaboration and stakeholder engagement.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca

Here, unexpected teams come together to push scientific boundaries—combining deep expertise with groundbreaking technology and an entrepreneurial approach to build long-lasting vaccines and highly targeted antibodies. We move quickly and precisely. We work together across fields and geographies. Our goal is to turn complex science into medicines that strengthen global preparedness and provide lasting protection. We value kindness alongside ambition, empower people to lead, and back them with the tools, investment, and partnerships needed to create evidence that improves lives at scale.

Date Posted

17-Sep-2026

Closing Date

16-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.