Senior Programming Specialist
Poolia Väst AB / Elektronikjobb / Göteborg
Observera att sista ansökningsdag har passerat.
Visa alla elektronikjobb i Göteborg,
Mölndal,
Partille,
Kungälv,
Lerum eller i
hela Sverige Visa alla jobb hos Poolia Väst AB i Göteborg,
Mölndal,
Partille,
Lerum,
Härryda eller i
hela Sverige We are seeking a highly motivated Senior Programming Specialist to help AstraZeneca Gothenburg shape the future of medicine! The 8-months consultant assignment will start as soon possible. To be considered for this exciting opportunity, please apply today.
Publiceringsdatum2019-04-17Om tjänstenBiometrics & 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
Dina arbetsuppgifter i huvudsak
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.
Vem är du?
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.
Om verksamheten
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.
Varaktighet, arbetstid
Heltid Visstid, mer än 6 månader
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-05-08
Ange följande referens när du ansöker: 53424
Klicka på denna länk för att göra din ansökanKontaktJenny Lundkvist
jenny.lundkvist@poolia.se 0720774415
FöretagPoolia Väst AB
AdressPoolia Väst AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4740371
Observera att sista ansökningsdag har passerat.