Collaborate with Clinical Development teams or CROs to meet project timelines for statistical data analysis and reporting
Oversee or independently produce and validate programming deliverables such as analysis datasets, tables, listings, and figures
Anticipate resource needs and coordinate with management to ensure long-term resource allocation for therapeutic projects
Ensure quality control (QC) is performed on all derived datasets, tables, listings, and figures in alignment with company standards and regulatory requirements
Participate in developing global programming standards to enable consistent deliverables across portfolios; create tools supporting SDTM/ADaM dataset generation and TLF production
Provide functional expertise in establishing BioNTech’s centralized clinical data repository, clinical data dictionary, and operational data dictionary
Collaborate with Biostatistics to develop statistical applications such as data review and reporting tools
Support regulatory submissions by preparing data submission packages including define.xml
Requirements
BSc in Statistics, Mathematics, Computer Science, or related discipline; advanced degree preferred
5+ years (3+ years with advanced degree) experience in pharmaceutical industry/CRO/clinical research settings