Director Statistical Programming SDTM Data Integration & Submission

Mainz, Germany | full time | Job ID: 11228About the role:As Director Statistical Programming SDTM Data Integration and Submission at BioNTech you will be responsible for providing strategic and operational leadership for clinical data integration and submission activities within Statistical Programming, ensuring consistent adoption of CDISC standards and BioNTech data governance expectations as well as providing expert guidance and oversight for SDTM mapping across projects, using CDS macro tools and established BioNTech standards.Your main responsibilities are:

• Lead the design, build, and lifecycle management of a clinical Metadata Repository (MDR)
• Oversee the generation of platform-based integrated SDTM data to support integrated analyses
• Collaborate with Integrated Analysis Statisticians to establish integration strategies, including
• Lead and coordinate the development of regulatory SDTM submission packages
• Act as an active member and leader within the clinical data standards and governance framework
• Provide leadership and oversight for internal and external resources supporting data integration and submission
• Partner closely with IT, Digital Data & Informatics (DD&I), Biostatistics, Data Management, Regulatory Affairs, and other stakeholders
• Ensure all activities are performed in accordance with applicable SOPs, GxP requirements, 21 CFR Part 11, data privacy regulations, and global regulatory expectations

• Bachelor's degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
• 12+ years (9+ years for advanced degree) of experience in statistical Programming or clinical data integration within the pharmaceutical, biotechnology or CRO industry
• Extensive experience with SDTM and ADaM standards and implementation across multiple clinical development phases and therapeutic areas
• Proven experience in leading regulatory submissions (e.g. NDA/BLA/MAA), including integrated analyses (ISS/ISE) and periodic reports (IB, DSUR, PBRER)
• Hands-on experience with CDISC-compliant SDTM mapping, integrated databases, and the development and deployment of standard macro tools
• Demonstrated experience in metadata repository (MDR) design, implementation, and governance, including metadata driven programming approaches
• Advanced proficiency with statistical programming languages and tools (SAS required; exposure to R and/or Python desirable), including working within a validated statistical computing environment (SCE) and/or cloud platforms
• Experience collaborating in cross functional, global/matrix organizations and managing work performed by external partners (e.g. CROs, technology vendors)
• Strong knowledge of clinical data structures (CRFs, EDC structures, external data, dictionaries such as MedDRA and WHODD) and their integration into standardized SDTM datasets
• Demonstrated ability to design and operationalize metadata-driven SDTM mapping strategies, including standard-based re-use, change management, and configuration of MDR solutions
• Experience with the development, validation, and governance of standard macro tools and automation pipelines to support SDTM mapping and integration
• Deep expertise in CDISC SDTM and ADaM standards, controlled terminology, and clinical data submission requirements (FDA, EMA, PMDA, NMPA)

Your Benefits:It's our priority to support you: * Your flexibility: flexible hours | vacation account * Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning * Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential * Your health and lifestyle: Company bike * Your mobility: Job ticket | Deutschlandticket * Your life phases: Employer-funded pension | Childcare Apply now - We look forward to your application!Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).Job ID 11228 (please always specify if you have any questions)By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.Inspired? Become part of #TeamBioNTech.BioNTech, the storyAt BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!BioNTech - As unique as you