Director Statistical Programming (Oncology)

• 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
• 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
• Lead the programming contribution to global regulatory submissions (e.g., NDAs, BLAs, MAAs), ensuring compliance with eCTD requirements

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.

• Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred
• 15+ years (10+ years for advanced degree) experience in a pharmaceutical industry, CRO or another clinical research setting, with a focus on oncology
• Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
• Solid understanding of FDA, EMA, ICH, and global regulations and guidelines and industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

At 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.