Senior Director, Biometrics Team Leader- Late Oncology Hematology at AstraZeneca in Gaithersburg, Maryland

Job Description:

This position could be based out of Gaithersburg - MD; Waltham - MA; South San Francisco - CA or Wilmington - DE.


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.


The extensive experience in the pharmaceutical industry to independently lead a biometrics team to deliver project and/or technical level activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions. Senior Director, Biometrics Team Leader- Late Oncology Hematology ensure Biometrics input and support for drug projects in a clinical development program across a business unit.


The accountabilities for the Senior Director, Biometrics Team Leader are:

• To globally lead, manage and develop a group of statisticians.


• Ensures drug projects are successfully delivered by leading biometrics support and strategy. This includes Development Plans, Regulatory Strategy and Submissions, high level internal governance committees, Health Technology Assessment and Reimbursement/Payer and Commercial support as appropriate for the stage of the product.


• Provide leadership to staff on the product world-wide so that all work is carried out with regards to AZ standards and external regulations.


• Develop collaboration with external opinion leaders, consultants, and collaborative groups.


• Provide leadership and direct contribution to functional and/or cross-functional improvement projects/activities/ initiatives.


• Lead Biometrics resourcing to deliver projects and provide input on internal vs outsourcing delivery.


• Maintain understanding and awareness of, as well and investigate and implement, new methodologies, therapy area and drug development advancements.


• Represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations or high level internal governance committees for specific projects/indications.
  

Required Skills:

• Master's degree with 10 plus years of experience, or PhD degree with 7 plus years of experience


• Extensive experience in late-phase oncology clinical development, with additional experience in cell therapy is a plus.

Preferred Skills:

• Advance degree in statistics, biostatistics, mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area


• Track record of background in leading independently


• In depth knowledge of technical/regulatory requirements with experience in pharma/healthcare


• Exemplary technical skills


• Excellent communication skills and ability to build strong relationships


• Managerial experience


• Excellent collaboration required - needs the energy to work across global & functional boundaries both internally and externally


• Vision - keen awareness of R&D priorities in order to apply novel solutions to scientific problems


• Travel - willingness to travel domestically & internationally

Why AstraZeneca?


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 recognising their potential. Join us on our journey of building a new kind of organisation 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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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now