Senior Programming Specialist to AstraZeneca
Alten Sverige AB / Apotekarjobb / Göteborg
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hela Sverige 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.
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.
About ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
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 Matilda Holthe at
matilda.holthe@alten.seVaraktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2019-04-18ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2019-05-08
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 4741544
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