Clinical Standards Developer Specialist

1 month ago


Ballerup, Denmark LEO Pharma Full time
Your role


• Develop and maintain programming solutions, such as standard SAS macros, APIs, tools to support the analysis and reporting of clinical trial data across various trials and clinical development projects
• Act as a superuser, providing day-to-day support to end-users of our Statistical Computing Environment and our analysis and reporting standards
• Ensure end-user training and assist with IT-related tasks, such as system upgrades
• Identify and address the needs of different stakeholders, including data management, statistical programming, biostatistics, and medical writing, providing input for prioritization.
• Support the technical implementation and adoption of clinical data standards
• Drive the adoption of clinical data standards from external organizations like CDISC and regulatory authorities


Your Qualifications


• Graduate qualification in mathematics, statistics, computer science, life sciences, or a related field, or equivalent work experience
• Strong proficiency in SAS programming
• Ability to develop and leverage SAS macros for efficient and scalable programming, automating repetitive tasks, and integrating with other systems
• Strong knowledge of CDISC standards and regulatory requirements
• Familiarity with handling and analyzing clinical trial data
• Excellent attention to detail and accuracy
• Good communication and interpersonal skills
• Positive mindset and ability to foster good collegial relations
• Ability to work both independently and collaboratively in a team environment

 



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