Associate Expert, Data Standards

Work Your Magic with us!Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

• Support the implementation and maintenance of data standards (including CRF, External Data, and SDTM) to ensure consistency across studies.
• Contribute to the creation of study-specific CRF (Case Report Form) metadata and SDTM (Study Data Tabulation Model) metadata
• Provide oversight for SDTM packages in outsourced studies, ensuring regulatory compliance, submission readiness, and adherence to standards (CDISC, FDA, EMA, etc.).
• Support eDC (electronic Data Capture) study set-up activities, including guidance to study teams for the build of non-standard CRF forms, and exemption management.
  

Who You Are

Minimum Requirements

• Bachelors degree in a relevant scientific or technical field, computer sciences, Data Management.
• 5-8 years of proven experience in the pharmaceutical or biotechnology industry.
• Proficiency with data management systems, with preference for experience in Rave Medidata.
• Good experience in eDC set-up activities, CRF build, and edit checks programming.
• Advanced knowledge of industry data standards and tools, including CDISC SDTM, CDASH, ODM-XML, and define.xml.
• Good understanding of regulatory requirements (FDA, EMA, CFDA, PMDA) and ICH-GCP guidelines.
• Strong analytical, problem-solving, and organizational skills.
• Strong attention to detail and accuracy in adhering to data standards and guidelines.
  

Preferred Requirements

• Rave Medidata eDC build certified, SAS programming
• Proficiency in data standard governance principles and their application in the pharmaceutical industry.
• Demonstrated ability to support and lead data standardization initiatives within assigned projects or domains.
• Willingness to collaborate and learn from experienced team members to expand knowledge and expertise.
  

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!