Clinical Standards Developer

Application deadline: 21st December 2025 
Location: Gdansk 80-309, Poland, Poland 
Contract type: Permanent 
Job ID: 3851 

Clinical Standards Developer

In this role you will define and direct the data management workflow for assigned projects and ensuring all necessary data quality control measures are in place and provide specific expertise on timeline development and identification of data management deliverables.

Join us in creating a future legacy in medical dermatology

At LEO Pharma, we are global leaders in medical dermatology. We have 115 years’ experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines. 

Your role

You will play a key role in serveing as the data management expert on multidisciplinary clinical project teams.

Key responsibilities:

• Implement process improvements related to clinical data standards.
• Support the technical implementation and adoption of clinical data standards.
• Play an active role in the governance of clinical data and programming standards.
• Overall responsibility for SDTM data at the trial level, including annotations, specifications, and Reviewer's Guide.
• Review Case Report Forms (CRF), annotate eCRF to SDTM, review Data Validation Plan (DVP), and create/review SDTM datasets.
• Assist in cleaning SDTM trial data and guide the implementation of LEO SDTM to CROs.
• Collaborate with Statistical Programming, Clinical Data Management, Biostatistics, and Medical Communication departments.
• Engage with external standards development organizations, authorities, CROs, software companies, and professional/scientific contacts.

Your qualifications

To succeed in this role, we imagine that you have the following qualifications/experience: 

• Diploma in life sciences/statistics/computer science/mathematics or similar.
• Minimum of 2 years of experience in overseeing SDTM creation, define.xml, annotated CRF, and Clinical Study Data Reviewer's Guides for regulatory submissions.
• Experience and understanding of programming and have an interest in learning new programs. 
• Experience with CDISC standards and regulatory guidelines.
• Ability to work with support from other functions on various levels of complexity within clinical trial programs.
• Understanding of regulatory requirements in specific therapeutic areas and their implications for clinical data processing and analysis.
• Ability to lead projects, drive timelines, and deliverables within the team

Your application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest. Please refrain from adding a photo to your CV. 

Beyond the skin

Become part of LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. We are are the legacy-builders of the future – enabling people to have a better today and tomorrow. With the world as our lab, we are transforming innovative ideas into more effective and easier-to-use medicines. Through collaboration and partnerships, we can do much more.  

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a fundamental difference.

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

Join us and make an impact in, on and far beyond the skin. Apply now!