Senior Specialist Programming at AstraZeneca Gothenburg
Dfind Science & Engineering AB / Kemiingenjörsjobb / Göteborg
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AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The Arena
Biometrics & Information Sciences (B&I) drives good design to generate data needed for quality decision making. B&I's goal 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.
Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure
Tasks and responsibilities/The role:
As a member of B&I Programming, collaborates with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:
• Data submission strategy (e.g., managing legacy data, pooling data)
• Responses to regulatory agency queries
• Tables Figures and Listings (TFLs)
• Development Safety Update Reports (DSURs)
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Investigators brochures (IBs)
• Office of Scientific Investigations (OSI) data sets and listings
• Regulatory and/or Payer submission related analysis data sets and/or TFLs
• Associated quality and process documentation as per applicable business processes
• Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
• Pharmacokinetics/pharmacodynamics data preparation and analysis
• Manipulating and analyzing adjudicated data
• Data preparation and analysis for Global Medical Affairs work
• Clinical Trial Transparency deliverables (data de-identification, results posting files)
• Timely upload of documents to eTMF
• Produce and maintain the technical database standards and Programming Specification documents.
• Contributes to and/or lead aspects of the provision of technical consulting expertise to external partners in relation to the specifications and delivery of the SDTM and ADaM databases by these partners.
• Contributes to and/or lead the development of best practice to improve quality, efficiency and effectiveness.
• Identify opportunities to improve the methodology and provide practical solutions for problems.
Minimum requirements
• BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
• Advanced SAS programming knowledge and experience.
• Knowledge of database set-up and report publishing requirements.
• Advanced knowledge of technical and regulatory requirements related to the role.
• Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.
• Advanced knowledge and experience of clinical drug development or healthcare.
• Develop and deliver training.
• Able to demonstrate team working and role leadership skills appropriate to level.
Desirable
• Advanced verbal, written, communication and collaboration skills.
• Advanced problem solving and conflict resolution.
• Helps 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 and quality focus. Troubleshoots for team.
• Contributes to defining business processes and accurately completes and manages associated documentation.
• Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
• Diligence - attention to detail and ability to manage concurrent projects and activities within those projects.
Business: Dfind Science & Engineering
City: Gothenburg
Deadline for applications: 2019-05-07. Selection is on-going and interviews will be held continuously which means the position can be filled before deadline. Please make sure to send in your application at your earliest convenience!
For more information contact: Eleonor Ehrman +46 (0) 73-343 41 09.
Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.
Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.
Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world's largest company within recruiting and staffing.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-04-17ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-05-07
Ange följande referens när du ansöker: 201215513
Klicka på denna länk för att göra din ansökanKontaktEleonor Ehrman +46 (0)73-343 41 09
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Södra Hamngatan 35
41114 GÖTEBORG
KontorsadressSödra Hamngatan 35, 41114 GÖTEBORG
Jobbnummer 4739947
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