Manage internal programmers or external vendors (CROs) to maintain quality, consistency, and compliance with CDISC standards and regulatory requirements
Hands-on review, validation, and troubleshooting of SAS/R programs for data transformation, analysis, and reporting
Ensure accuracy of efficacy/safety outputs, perform quality control (QC), and resolve discrepancies in collaboration with Biostatistics and Data Management teams
Serve as the primary programming point of contact for study teams and partner with Biostatistics to interpret analysis requirements, with Clinical Operations to address data issues, and with Regulatory Affairs to prepare submission-ready materials (e.g., ISS/ISE, CSR appendices)
Manage relationships with outsourced programming partners (CROs), including scope negotiation, timeline oversight, and quality audits
Anticipates resource needs and monitor resource allocation across studies to balance workload and ensure deliverables meet deadlines
Develop and implement standardized macros, tools, or workflows to improve efficiency across studies
Train junior programmers and CRO staff on BioNTech standards, best practices, and emerging regulatory guidance (e.g., FDA/ICH updates)
Provide programming support to the regulatory submissions including data submission package and define.xml development

Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
10+ years (5+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting
Excellent knowledge of statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
Oncology and project management experience is required
Strong interpersonal skills in addition to exceptional written and oral communication skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions
Ability to work in a fast-paced, dynamic, and a team environment

Associate Director, Statistical Programming – Oncology

Key skills