Sr Director, Late Statistics- Head of Breast Cancer Strategy
- Experience Level
- Senior Management
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Our Biometrics department drives design to generate data needed for quality decision making. Our goal is to drive excellence in delivery, improve decision making, while engaging and shaping the external environment by accessing and implementing innovative solutions.
We oversee and deliver all the statistical contribution to design, decision-making, interpretations and communication internally and externally for our therapeutic area portfolio.
The Senior Director, Late Oncology Statistics - Head of Breast Cancer Strategy, will lead, manage and develop a group of statisticians that support Late Development. Lead the strategic and operational planning of the Biometrics contributions to the Development Plans, Regulatory Strategy and Submissions, Health Technology Assessment and Commercial support of AZ products- specifically for the Breast Cancer portfolio
- Provide statistical support to research, TA, manufacturing, operations, and biosimilars
- Statistical support to clinical trials including trial design, definition of endpoints, and Go/No Go criteria
- Lead regular Biometrics Team meetings to ensure efficient communication
- Provide transparency on team members' responsibilities and Health Authority interactions by maintaining an accountability thread through TA Head
- Developing design options and providing high quality decision support
- Quantifying the benefit, risk, value and uncertainty of the emerging product profile.
- Setting the standards (and carrying out compliance) for statistical work within the product;
- Hold our external partners accountable to our high quality standards of deliverables
- This person will represent AZ's Statistics group to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications;
- Promote, investigate, develop and implement novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
- Defines strategies or leads AstraZeneca's response to sophisticated technical issues for specific medical/statistical aspects within the TA in relation to current projects and, new projects.
- Maintains a high degree of understanding and awareness on new methodologies, therapy area and Development initiatives
- Develops and maintains relationships with international opinion leaders, consultants and collaborative groups.
- Represents AZ in cross industry drug development initiatives
- To ensure drug projects are successfully delivered in terms of scientific leadership and resourcing
- Manager of group of Biometrics Team Leaders, Statistical Science Directors, Principal and/or Senior Statisticians
- Efficiently utilize resource in group and beyond to balance tactical and strategic business impact
- Accountable for the statistical work on the products worldwide
- Bachelor's degree, Master's degree, or PhD degree with significant years of experience
- Advance degree in statistics or mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
- In depth knowledge of the technical and regulatory requirements related to the role
- Recognized specialist of development, programme design and data analysis and interpretation
- Experience of major regulatory interactions and/or submissions
- Recognized externally as a specialist in statistics and clinical development
- Managerial experience
- Excellent communication skills and ability to build positive relationships
This role can sit at our Gaithersburg, MD; Cambridge, UK; or Waltham, MA location
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next?
- Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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