Application Development Bureau Chief

Found in: Jooble US O C2 - 2 weeks ago

Boston MA, United States AstraZeneca GmbH Full time

The Executive Director, Biostatistics has extensive experience in the pharmaceutical industry to independently lead a therapeutic area biostatistics team (e.g. Neurology, Metabolics, Hematology/Nephrology, Metabolism or other) to deliver project, tools and/or technical level activities related to design, delivery and interpretation, advises statisticians across business units to prepare for high level internal governance committees and/or regulatory submissions.
Manage performance of direct reports, ensure development and succession planning. Serve as an internal statistical expert/consultant across the business unit for own area of expertise
Coordinates the review of any new proposed external regulatory guidelines where statistical expertise input is needed and serves as the statistical representative on cross functional reviews of such guidance documents
Influences and develops contacts with international opinion leaders, consultants, and collaborative groups
Provide leadership and direction to improve internal and external projects/activities/ initiatives, e.g. study design consultations and specialized statistical expertise for ongoing and completed studies
Known by other experts in their field. Invited speaker and chair at multiple major conferences/groups. Identify & drive the development & utilization of leading-edge statistical methodology, skills, capabilities, tools, processes & best practice, in order to add value to drug development
Work with the VP of Quantitative Statistics on overall analytics strategy, and provide senior level technical expertise regarding statistical capabilities & solutions
Develop collaborative relationships with the external scientific/academic community
Steer & support development & maintenance of any required tools & processes in a manner that meets regulatory and evidential requirements
Communicates new methodology externally through workshops and training
Work according to agreed functional and regional Safety, Health and Environment (SHE) strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements
MSc in statistics or relevant topic with relevant clinical trial and/or pharmaceutical industry experience
In depth knowledge of technical/regulatory requirements with experience in pharm/healthcare
Vision – keen awareness of R&D priorities in order to apply novel solutions to scientific problems
Flexible, well-organized, and possess the ability to work well under pressure.
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; PhD in Statistics/Biostatistics is preferred.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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 welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

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