Clinical Standards Developer Specialist

Field of work: Clinical Development

Posting Date: 11 Apr 2024

Application deadline: 19-APRIL-2024
Location: Ballerup 2750, , Denmark
Contract type: Permanent
Job ID: 1869

Role Description
Do you have strong skills in SAS and maybe some proficiency in other programming languages such as R or Python? Are you adept at analyzing programming issues and providing effective solutions? Are you passionate about being the expert behind our most valued standard solutions and data flow automation initiatives? If so, we have an exciting opportunity for you to join our Statistical Programming team as a Clinical Standards Developer Specialist.

At LEO Pharma, we value collaboration and fostering strong internal relationships. As a Clinical Standard Developer, you will play a vital role in maintaining and further developing our clinical data standards, including SDTM, ADaM, and TFL standards. You will contribute to a multilingual programming environment where the creation and quality control of data packages and statistical outputs are standardized to ensure consistency and accuracy.

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

Contact and application

If you are an experienced Statistical Programmer or Standards Developer seeking a new challenge and a supportive work environment, we encourage you to submit your resume and a cover letter highlighting your relevant experience. We are excited to hear from you and eagerly await your application.

Please note that only shortlisted candidates will be contacted.

We offer a competitive salary and benefits package, as well as ample opportunities for growth and professional development. While we prefer candidates to be on-site at our office in Ballerup, Denmark at least three days a week, we are also open to considering

remote work arrangements for candidates residing in countries where LEO Pharma's affiliates are located

Let’s pioneer together
At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.

At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.

For certain positions, LEO Pharma might complete a background check conducted by a third party.