Senior Clinical Data Engineer M/F/X

About Boehringer Ingelheim GmbH

We are Boehringer Ingelheim, a global organization within the Human Pharma Business Unit, focused on transforming Biostatistics and Data Sciences into a modern data science organization in clinical development. Our team promotes a collaborative working model emphasizing cross-functional, self-organized teams to deliver customer-validated value. We offer challenging positions in a respectful and collegial global working environment, prioritize continuous development, and advocate for diversity and inclusion. We are located in Ingelheim or Biberach, providing opportunities for growth and innovation.

Role

At Boehringer Ingelheim GmbH we are looking for a Data engineer!

Tech Stack

• GCP
• Support
• Product Owner
• SAS
• Cloud
• Data

Requirements

• Bachelor or Masters 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
• Knowledge in and experience with Data Collection Tools (EDC systems), Data Review Tools, and understanding of CDISC standards (CDASH, SDTM, etc.)
• Technical expertise and/or programming skills (preferably SAS or R)
• Strong organizational skills, problem-solving abilities, time management skills, and initiative-taking
• Excellent communication skills and fluency in English, both spoken and written
• Advanced experience in leading complex projects, ideally within cross-functional or global environments (for Principal role)
• Demonstrated expertise in late-phase clinical development, including regulatory submission processes and interactions with health authorities (for Principal role)
• Strong proficiency and hands-on experience with relevant programming languages such as SAS or R (for Principal role)
• Experience working in or with agile teams and/or serving as a Product Owner is considered a strong advantage (for Principal role)

Responsibilities

• Ensure the delivery of high-quality clinical trial data, enabling informed decision-making to accelerate the availability of our drugs to patients.
• Act as a key liaison to establish, align, and confirm data management activities for assigned late-phase trials, collaborating regularly with internal and external partners.
• Review clinical trial protocols to identify data capture requirements, define eCRFs and clinical trial databases, and oversee the creation and maintenance of essential TMF documentation.
• 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.
• Specify, integrate, and reconcile external data from vendors or internal departments into the clinical trial database, ensuring SDTM-compliant data delivery.
• Contribute to knowledge sharing by presenting and training at CRA/Investigator meetings and onboarding new colleagues.
• Ensure compliance with ICH GCP guidelines, global regulatory requirements, and industry standards for data management processes, while participating in regulatory agency and internal audits.
• Lead complex technical concepts and shape overarching data strategies (for Principal role).
• Identify opportunities to improve and optimize data processes (for Principal role).
• Mentor and support the development of Clinical Data Engineers across the organization (for Principal role).
• Drive digital innovation initiatives that span across organizational boundaries (for Principal role).

Benefits

No benefits listed.