Senior Programming Specialist at AstraZeneca, Gothenburg
Modis Sweden AB / Biologjobb / Mölndal
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hela Sverige Modis is a staffing & recruiting company and is part of the Adecco Group, the world 's leading HR-solutions provider across 60 countries. This scale and scope ensures Modis is truly a global community. Our mission is to be the Leading Professional Services Company by finding the right match between you as a candidate and you as a customer. We are a team with various and complementary backgrounds within Life Science, Engineering and Technology. We can ensure that we understand our customer needs and we can ensure that we understand the competence-profiles of our applicants and candidates.
We are now seeking for a Senior Programming Specialist to AstraZeneca, Gothenburg. This opening is a consultant assignment for at least 6 months.
About the customer
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.
Please submit your application already today, or by latest 2019-05-08 by attaching your CV and personal letter in English (interviews are held continuously).
If you have any questions about the assignment, do not hesitate and contact Markus Dahl (
markus.dahl@modis.se).
Varaktighet, arbetstid
Heltid Full time (40h/week)
Publiceringsdatum2019-04-17ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-05-08
Klicka på denna länk för att göra din ansökanKontaktMarkus Dahl
FöretagModis Sweden AB
AdressModis Sweden AB
Hamngatan 13
11146 Stockholm
KontorsadressHamngatan 13
Jobbnummer 4739317
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