SAS programmer
Poolia Göteborg AB / Biomedicinjobb / Göteborg
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hela Sverige We are now looking for a talented SAS programmer for AstraZeneca Gothenburg. The 12-months consulting assignment will start as soon as possible. If you are interested, apply today!
About the consulting assignment
The Arena:
Biometrics & Information Sciences (B&I) is the home of late stage drug development biometrics
activity at AstraZeneca and consists of experts in statistics, programming, informatics and
information science. B&I drive good design and standards to generate the data needed for
quality decision making on. 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. 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. TA Programming is the group that oversees and delivers all the
programming contribution to internal decision making, regulatory submissions and reporting
and commercial activities for the TA portfolio of projects.
Tasks and responsibilities/The role:
As a SAS programmer you will collaborate with the Programming Leader to provide support for
aspects of the clinical development process, including clinical development plans, regulatory
submissions, commercialisation and scientific utilisation data for AZ products. You will Report
to Programming Team Leader and provide programming support to deliver technical
programming and information components of a project, including but not limited to:
• Regulatory response to agency queries
• Development Safety Update Reports (DSUR)
• Periodic Benefit-Risk Evaluation Report (PBRER)
• Investigators brochures (IB)
- Data submission strategy, i.e., legacy data, pooling data, communications with
regulatory agencies
• Outcomes studies
• Pharmacokinetics/pharmacodynamics data preparation and analysis
• Manipulating and analyzing adjudicated data
• Delivering Clinical Trial Transparency (data de- identification)
• Data preparation and analysis for Global Medical Affairs work
In the role you will:
• Produce and maintain the technical database standards and Programming Specification
documents
• Contribute to the provision of technical consulting expertise to external partners in
relation to the specification and delivery of the SDTM and RDB databases by these
partners
• Provide support to the regulatory submissions including specification and delivery of
overview databases, outputs and response to regulatory questions
• Identify opportunities to improve the methodology and provide practical solutions for
problems
• Contribute to the development of best practice to improve quality, efficiency and
effectiveness
About you
Minimum requirements:
• BSc in Mathematical, Statistical, Computer Science or Life Science
• Extensive SAS programming experience
• Knowledge of database set-up and report publishing requirements
• Knowledge of technical and regulatory requirements related to the role
• Knowledge of CDSIC standard and industry best practices
• Experience in clinical drug development or healthcare
• Excellent verbal and written communication skills
• Assist in developing and delivering training
Preferred experience and key factors:
• BSc in Mathematical, Statistical, Computer Science or Life Science
• Contributes to innovating and streamlining workflows
• Knowledgeable of the drug indications within a therapeutic area and data submission
standards within that therapeutic area.
• Contributes to assessing and mitigating risk within a protocol or drug project and
proactively determining the need and/or level of escalation
About AstraZeneca
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.
Warmly welcome to Poolia Life Science Göteborg and AstraZeneca!
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-10-24ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-10-31
Ange följande referens när du ansöker: 51706
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4420765
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