Associate Director/Director, Statistical Programming
AstraZeneca / Biomedicinjobb / Göteborg
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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 late-stage development drug project pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.
As Programming Team Leader (PTL) within Diabetes and Metabolic Disease, you will lead and direct statistical programming project contributions in collaboration with B&I drug project team leaders and members. You will ensure the timeliness and quality of Programming's contributions to health authority and payer submissions, including specification and delivery of databases, reports, and responses to regulatory questions.
You will work in in the Programming department that oversees and delivers global programming aspects of late-stage clinical development, manages and maintains the end-to-end standards and manages and maintains the analysis and reporting production tools and information infrastructure.
The Diabetes and Metabolic Disease (DMD) Therapeutic Area (TA) Programming group oversees and delivers all the statistical programming contributions to internal decision making, regulatory submissions and reporting and commercial activities for the portfolio of drug projects within DMD.
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 DMD Therapy Area Programming Director (TAPD) you will act as the senior Programming leader at the drug project level, providing support for all aspects of the clinical development process including, but not limited to, development plans, project strategy, regulatory submissions, programming and information deliverables, commercialisation and scientific utilisation data for AZ products.
You will lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and analysis (ADaM) databases by these partners. This will include ensuring the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable. In this role, you will have accountability for the quality of elements of project programming work worldwide. You will work to improve quality, efficiency and effectiveness by contributing to the development of best practice and identifying opportunities to improve the methodology, providing practical solutions for problems.
Essential Requirements
* BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science
* Extensive SAS programming expertise to an advanced level
* Comprehensive knowledge of technical and regulatory requirements related to the role
* Knowledge of CDSIC standards and industry best practices
* Extensive experience in clinical drug development or healthcare
* Experience in Regulatory submissions
* Excellent verbal and written communication skills and influence stakeholders
* Advanced to expert verbal and written communication and collaboration skills.
* Advanced to expert problem solving and conflict resolution.
* Drive others to work across global & functional boundaries.
* Travel - willingness and ability to travel domestically and/or internationally.
* Ability to apply programming knowledge and skills to problems, problem solving, and quality focus. Troubleshoots for team.
* Contributes to defining business processes and accurately completes and manages associated documentation.
* Diligence - attention to detail and ability to manage concurrent projects and activities within those projects.
Desirable Requirements
* Other programming languages e.g. S-PLUS, R, XML etc.
* Extensive knowledge of Open CDISC Validator
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, gender or gender 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 - 28th February
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-02-08ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-02-22
Ange följande referens när du ansöker: R-036652
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
sara.jagevall@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4602170
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