Executive Director, Head of Biometrics, Infectious Disease

The Opportunity

Are you an expert in biometrics statistics or statistical programming ready for a transformative leadership opportunity Would you like to play a pivotal role in the development of potential medicines and vaccines addressing some of the greatest unmet medical needs in infectious diseases

The Infectious Disease unit was created to optimize AstraZenecas 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.

AsHead of Biometrics for Infectious Disease you will have a unique opportunity to further elevate the Infectious Disease Therapy Area in one of the worlds most respected biopharmaceutical companies. You will be a core member of theLate Infectious Disease Development Leadership Team leading the global capability for biostatistics statistical programming and associated disciplines supporting the ID pipeline.

Strategic Priorities

Drive Quantitative Strategy: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.

Champion Statistical Innovation:Push the boundaries of modern statistical methodsincluding innovative trial design digital sensor data analysis and AI-enabled approachesthrough collaboration publication and scientific exchange with external academic and industry groups.

Build and Grow World-Class Talent: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.

Strengthen External Influence:Maintain a wide set of collaborative relationships with academics KOLs regulators and cross-industry groups to enhance AstraZenecas external standing and bring new ideas in-house.

Key Accountabilities

Leadership & Team Development

Lead and develop a cross-skilled team of statisticians programmers and other relevant disciplinesincluding individual contributors and team leaderswithin 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.

Scientific & Technical Excellence

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 reportingincluding 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 opportunitiesspecifically accountable forquantifying 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.

Cross-Functional Collaboration & Governance

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.

Regulatory & External Engagement

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.

Essential Qualifications & Experience

PhDin Biostatistics Applied Mathematics Statistics or other relevant quantitative discipline (MSc considered with exceptional experience) with aminimum of 5 yearsof pharmaceutical/life sciences industry experience.

• Demonstrated expertise in multiple statistical modalities acrossPhase IIV 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 structureincluding 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 withglobal regulatory submissionsand interactions with major Health Authorities. Experience presenting to FDA Advisory Committees is a plus.
• 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.

Essential Skills & Attributes

• Strategic Leadership:Proven ability to drive strategy in a pharmaceutical development environment working collaboratively with cross-functional stakeholders at all levels.
• Team Development:Demonstrated ability to lead coach mentor and motivate high-performing teams in a global matrix environment.
• Cross-Functional Collaboration:Demonstrated ability to cultivate excellent partnerships and resolve conflicts across a broad stakeholder base.
• Communication:Excellent communication skills with the ability to present data strategy and innovation to upper management and in public venues.
• AI & Digital Mindset:Demonstrated experience applying AI-enabled and generative AI tools to support clinical development activities (e.g. data analysis medical writing clinical trial operational efficiency).
• Change Management:Positive change-management skills and pedigree with resilience and the ability to motivate others in a dynamic environment.
• Integrity:Must demonstrate high integrity and independence.
• Travel:Willingness and ability to travel domestically and internationally.

Desirable Experience

Experience with medicine or vaccine development ininfectious diseases.

• Significant and consistentpeer-reviewed publicationtrack record.
• Experience with externalization models and managing outsourcing collaborations.

Why AstraZeneca

We are changemakers on the world stage at an exciting frontier of medicinebacked by deep knowledge and experience in our field. We lead the way into the future with energy and drive helping to transform healthcare and build pandemic preparedness to protect against future health crises.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the officewhile respecting individual flexibility.

This is a place for those who thrive on energy and pace. We seek the best data-driven solutions using cutting-edge methodologies and models to drive scientific breakthroughs. We dont accept the status quowe dig deep to see what the data is telling us. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $278568.00 - $ positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.