Director, Statistical Programming – SDTM Data Integration & Submission

Role Overview

• Lead the design, build and lifecycle management of a clinical metadata repository (MDR)
• Oversee the production of platform-based integrated SDTM data to support integrated analyses
• Collaborate with integrated analysis statisticians to define integration strategies
• 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 conducted in compliance with applicable SOPs, GxP requirements, 21 CFR Part 11 regulations, data privacy rules and global regulatory expectations

Requirements

• Bachelor's degree in Statistics, Mathematics, Computer Science or a related field; advanced degree preferred
• 12+ years of experience in statistical programming or clinical data integration in the pharmaceutical, biotechnology or CRO industry (9+ years with an advanced degree)
• Extensive experience with SDTM and ADaM standards and their implementation across multiple clinical development phases and therapeutic areas
• Proven experience leading regulatory submissions (e.g., NDA/BLA/MAA), including integrated summaries and periodic reports (e.g., ISS/ISE, Investigator’s Brochure, DSUR, PBRER)
• Hands-on experience with CDISC-compliant SDTM mapping, integrated databases and development/implementation of standardized macro tools
• Demonstrated experience designing, implementing and governing metadata repositories (MDR), including metadata-driven programming approaches
• Advanced skills in statistical programming languages and tools (SAS required; knowledge of R and/or Python desirable), including working within a validated Statistical Computing Environment (SCE) and/or cloud platforms
• Experience collaborating within cross-functional, global/matrix organizations and managing work by external partners (e.g., CROs, technology vendors)
• Strong knowledge of clinical data structures (CRFs, EDC structures, external data, and dictionary structures such as MedDRA and WHO-DD) and their integration into standardized SDTM datasets
• Proven ability to design and operationalize metadata-driven SDTM mapping strategies, including standards-based reuse, change control and configuration of MDR solutions
• Experience developing, validating and governing standardized macro tools and automation pipelines to support SDTM mapping and integration
• Deep knowledge of CDISC SDTM and ADaM standards, controlled terminology and clinical data submission requirements (FDA, EMA, PMDA, NMPA)

Tech Stack

• Cloud
• Python

Benefits

• Flexible working | Time-off account
• Digital learning | Performance and talent development | Leadership development | Training | LinkedIn Learning
• A voice at the table | Collegial culture | Opportunities to influence & contribute | Support to reach your full potential
• Company bike
• Job ticket | Deutschlandticket
• Employer-funded pension plan | Childcare support