Senior Clinical Data Engineer

The Position

Biostatistics and Data Sciences (BDS) is a global organization within the Human Pharma Business Unit. Working in close collaboration with other functions at Boehringer Ingelheim and external vendors we combine methodological and technical data science skills with business and scientific expertise to drive smart, timely and confident decision making at late stage of drug development, approval and access. 

On our journey to transform BDS into a modern data science organization in clinical development capable to thrive in a world of rapid and continuous change, we have changed our working model towards an operating model with emphasis on cross-functional and self-organized teams creating customer-validated value. This also will be supported by development teams focusing on optimization of processes and best use of systems in the capability management area. 

As a Senior Clinical Data Engineer, you are the key contact partner in cultivating the "power of data" by means of data collection/curation, data review, delivery and data standardization. You will be an active member of a BDS development team.

Tasks & responsibilities

• In your new role, you will be responsible and accountable for ensuring the delivery of high-quality clinical trial data, enabling informed decision-making to accelerate the availability of our drugs to patients.
• Acting as a key liaison, you will establish, align, and confirm data management activities for assigned late-phase trials, collaborating regularly with internal and external partners.
• With your expertise, you will review clinical trial protocols to identify data capture requirements, define eCRFs and clinical trial databases (including UAT and edit check specifications), and oversee the creation and maintenance of essential TMF documentation, such as CRF specifications, annotated eCRFs, and Data Management Plans.
• You will ensure data integrity by creating and executing data quality checks throughout the study, providing sponsor oversight of CROs or external data providers, and collaborating with trial teams to achieve timely database closure and lock.
• Leveraging your technical skills, you will specify, integrate, and reconcile external data (e.g., digital data, ePRO, bioanalytical data) from vendors or internal departments into the clinical trial database, ensuring SDTM-compliant data delivery and addressing Pinnacle 21 Enterprise outputs as needed.
• You will contribute to knowledge sharing by presenting and training at CRA/Investigator meetings, onboarding new colleagues, and conducting trainings within the Clinical Data Engineering community.
• In addition, you will ensure compliance with ICH GCP guidelines, global regulatory requirements, and industry standards for data management processes, while participating in regulatory agency and internal audits.

Requirements

• Bachelor's or master's degree (e.g. MBA, MSc) in Life Sciences, Computer Science, Software/Computer Engineering, or related fields, with several years of experience in clinical development, especially in Clinical Data Management; alternatively, high-qualified/multifaceted professional qualifications with relevant professional experience
• Experience in working in agile teams and/or as a product owner, with an understanding of dependencies among interfaces; knowledge of standardization methods and requirements is a plus
• Knowledge in and experience with Data Collection Tools (EDC systems), Data Review Tools, and understanding of CDISC standards (CDASH, SDTM, etc.) is beneficial
• Technical expertise and/or programming skills (preferably SAS) is a plus
• Strong organizational skills, problem-solving abilities, time management skills, and initiative-taking
• Excellent communication skills and fluency in English, both spoken and written

Ready to contact us? 

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com 

Recruitment process: 
Step 1: Online application - The job posting is presumably online until October 20th, 2025. We reserve the right to take the posting offline beforehand. Applications up to October 6th, 2025 are guaranteed to be considered. 
Step 2: Virtual meeting in the period from mid till end of October
Step 3: On-site interviews beginning of November