Mathematician as Director (m/f/d)

Director Statistical Programming (Oncology) London, United Kingdom; Mainz, Germany; Munich, Germany; Paris, France; Randstad, Netherlands | full time | Job ID:8854 Work alongside with Head of Statistical Programming to implement a comprehensive strategy to maximize efficiency in statistical analysis and reporting that encompasses vendor management, technological innovation, process automation, and adherence to industry standards Oversee a team of FSP programmers or vendor CROs to ensure timely, high-quality delivery of analysis datasets, tables, listings, and figures (TLFs) across multiple clinical trials Align programming strategies with compound/platform objectives and regulatory requirements (e.g., CDISC standards, FDA/EMA guidelines) Drive the creation, review, and validation of SAS/R programs for clinical data analysis, including SDTM/ADaM datasets, efficacy/safety outputs, and integrated summaries Ensure adherence to SOPs, regulatory standards, and reproducibility Partner with Biostatistics, Clinical Development, Data Management, and Regulatory Affairs to shape clinical study designs, statistical analysis plans (SAPs), and submission strategies to meet project deliverables and timelines for statistical data analysis and reporting Represent programming in clinical study team and other key meetings (e.g., protocol reviews, submission readiness) Lead the programming contribution to global regulatory submissions (e.g., NDAs, BLAs, MAAs), ensuring compliance with eCTD requir