Senior Clinical Standards Developer

Application deadline: 17.11.2024 
Location: Gdansk 80-309, Poland, Poland 
Contract type: Permanent 
Job ID: 2662 

Shape the LEO Pharma of tomorrow   

At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to becoming the leaders in medical dermatology worldwide. If you're ready to make a difference, this role is your gateway to a world of opportunities! 

In this role you will facilitate and promote the implementation, design, use, management, and maintenance of clinical data standards and programming standards from protocol development to regulatory submission.

Your Role 

As a Clinical Standards Developer you will: 

• 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.
• Act as a superuser and provide day-to-day support to end-users.
• 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 excel in this role, you will need: 

• DIploma in mathematics/statistics/computer science/life sciences or similar.
• Minimum of 4-5 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 SAS programming and relevant computing environment.
• Extensive 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

At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities. 

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.  

Beyond the skin  

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.   

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 difference.  

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

Join us on our journey Beyond the Skin. Apply today!