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Company

Original Job Post

AstraZeneca · 2 days ago

Biometrics Team Leader, Sr. Director Statistics

Boston, MA

Full-time

Onsite

Director

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Comp. & Benefits

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Responsibilities

Lead the strategic and operational planning of the R&I/Cell therapy Biometrics contributions, to the Development Plans, Regulatory Strategy and Submissions, Health Technology Assessment and Commercial support of AZ products.

Provide leadership for Biometrics staff world-wide so that all work is carried out with regards to AstraZeneca standards and external regulations.

Provides critical review and input on disease area and portfolio strategies, risk planning and mitigations.

Ensure product/disease area/portfolio global strategies considering key regional requirements in close collaboration with regulatory, medical, and commercial from the regions.

Leads discussions both internally and externally and develop strategies on novel development tools such as novel endpoints/biomarkers, novel study designs, digital tools.

Provide leadership and direction to improvement projects/activities/initiatives and drive the implementation of best practice across the department.

Together with your team lead colleagues secure biometrics delivery of the whole R&I portfolio.

Represent AstraZeneca and Statistics to Health Authorities and Reimbursement/Payer organizations.

Investigate and implement statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.

Develop contacts with international opinion leaders, consultants, and collaborative groups.

Effectively represent the Biometrics function in senior level interactions at internally governance technical review committees e.g. Development Review Committee (DRC/eDRC), Early Development Review Board, Global Medical Affairs (GMA) Review Committees.

Be aware of, and comply with, all appropriate AZ and R&D Cell Therapy Immunology procedures.

Maintain good collaboration across the AZ internal Biometrics community, including colleagues in R&I, CVRM, V&I, Oncology and in CMO.

Qualification

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Regulatory ComplianceProblem-SolvingCommunicationRelationship BuildingR&D PrioritiesScientific ProblemsManagerial Experience CollaborationVision

Required

MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognized equivalent to stats MSc

Track record of background in leading independently

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

Exemplary technical skills

Excellent communication skills and ability to build strong relationships

Preferred

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

Company

AstraZeneca

Glassdoor

4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor AB.

Founded in 1999