Director of Biometrics Safety Reporting
AstraZeneca / Kemiingenjörsjobb / Göteborg
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Salary - Competitive salary and company benefits apply
At AstraZeneca every one of our employees makes a difference to patient lives every day. Each one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.
At AstraZeneca our Biometrics & Information Sciences (B&I) department is an integral part of Global Medicines Development (GMD) and drives good design to generate the data needed for quality decision making. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.
As the Director of Biometrics Safety Reporting within B&I Technology Solutions (BITS) you will lead the Biometrics Safety Reporting to simplify and standardise periodic operational Safety Reporting, improving access to data, increasing support for Patient Safety initiatives within Global Medicines Development (GMD).
Programming is the department that oversees and delivers the programming aspects of clinical development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.
B&I Technology Solutions (BITS) is the business unit that leads design, programme management and delivery of Biometrics technology infrastructure, defines and delivers Programming's Systems & Tools Project Portfolio, manages and maintains the Analysis and Reporting production tools and information infrastructure, and delivers project and study-level safety reporting across the late-stage drug project portfolio.
If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.
Main Duties and Responsibilities
Reporting to the Head of B&I Technology Solutions you will be part of the Extended Programming Leadership Team and will have a number direct reports (4-20). You will ensure the Biometrics Safety Reporting group develops, implements, and champions relevant standards for data integration and analysis and reporting.
You will ensure consistent approaches to safety data standards and integration through expert information management and leadership, as well as utilization of best practices to enhance the value and contribution of Programming across late-stage drug projects. This will be achieved by collaborating with RDI/IT, Clinical Operations, GRAPSQA, and other Science Units and stakeholders you will influence the data and information infrastructure, and study/project-level safety reporting delivery and technology, across AZ/Medi drug development.
You will develop strategies, provide expert advice and influence, and/or lead AstraZeneca's response to complex challenges within AZ drug development related to data and information infrastructure, and study/project-level periodic safety reporting delivery and technology.
Essential Requirements
* BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science.
* Broad understanding of clinical drug development process and the contribution of different skills.
* Proficient knowledge of CDISC standards and global regulatory submission requirements
* BSc in mathematical, computer science or life sciences (postgraduate degree preferred), with experience in Pharmaceuticals/Healthcare and Clinical Drug/Medical Device Development.
* In-depth experience in end-to-end software tool/solution development and lifecycle management.
* Proficient knowledge of databases and repositories, relevant programming & scripting languages, hardware & software architecture, and enterprise system implementation.
* Proven leadership and professional skills that will enable strong leadership of a diverse team in a cross-company partnership re culture, geography, education etc.
* Relevant knowledge and experience for statistical programming (e.g., SAS, R) and data visualization tools and methods to an advanced level.
* Strong collaboration, communication, and stakeholder management skills.
* Current knowledge of other technical and regulatory requirements relevant to the role.
* Able to leverage experience to innovate and streamline workflows
* Knowledgeable of data submission standards and regulatory guidance
* Able to effectively assess and mitigate risk and proactively determine the need and/or level of escalation
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Closing date for applications - 14th March 2018
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-02-12ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-02-26
Ange följande referens när du ansöker: R-022338
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca UK
jonathan.duckworth@astrazeneca.comFöretagAstrazeneca
AdressAstrazeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 3958836
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