SAS Programmer to AstraZeneca
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige ALTEN Pharma in Gothenburg is looking for a SAS Programmer for a consultancy assignments at AstraZeneca in Mölndal.
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) 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
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 ALTEN
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-10-24ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-31
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4420065
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