Director, Statistical Programming

Role Overview

• Lead the programming contribution to global regulatory submissions (e.g., NDAs, BLAs, MAAs, rolling submissions, emergency use authorizations) for Infectious Diseases assets, ensuring compliance with eCTD requirements, and high‑quality, submission‑ready datasets, TLFs, and documentation (e.g., define.xml, reviewers’ guides)
• Develop and oversee data standards, tools and automation for efficient production and verification of derived datasets (e.g., SDTM and ADaM) and TLFs, including portfolio‑wide solutions for recurrent endpoints (e.g., virology, immunogenicity, efficacy and safety outcomes) in infectious diseases
• Drive the creation, review, and validation of SAS/R programs for clinical data analysis across multiple infectious disease studies and integrated analyses, ensuring compliance with SOPs, regulatory standards, and principles of reproducibility and traceability
• Collaborate cross‑functionally with Clinical Development, Clinical Operations, Pharmacovigilance, Regulatory Affairs, Translational Medicine, and other stakeholders to meet project deliverables and timelines for statistical data analysis and reporting across the Infectious Diseases portfolio and representing statistical programming in clinical study teams, portfolio governance, protocol reviews, and submission readiness meetings
• Guide and collaborate with internal Global Biometric Sciences (GBS) project leads and CRO/FSP staff to ensure alignment with established data, analysis, and quality standards.
• Provide direction and oversight to external partners delivering programming services for Infectious Diseases projects
• Champion the adoption of advanced analytics, automation tools (e.g., SAS macros, R/Python workflows), and new technologies (e.g., AI/ML, data visualization, decentralized trials, real‑world evidence) within the Infectious Diseases portfolio to enhance programming efficiency and scientific insight
• Identify, define, and monitor programming metrics to assess performance and quality for the Infectious Diseases portfolio. Evaluate existing processes and guidelines, propose enhancements, and implement changes for continuous process improvement and operational excellence
• Participate in, and as appropriate lead, continuous improvement activities and process reengineering initiatives in support of BioNTech’s global clinical and data strategy, contributing Infectious Diseases portfolio perspectives and requirements
• Provide leadership, coaching, and mentoring to programming staff (internal and external) supporting Infectious Diseases, fostering technical excellence, professional development, and a culture of collaboration and innovation

Requirements

• 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 infectious diseases
• Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
• Solid understanding of FDA, EMA, ICH, and global regulations and guidelines
• Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
• Solid understanding of the drug development process from early
• to late-stage development and submission
• Expertise in the requirements and technology to support electronic submissions
• Strong project and portfolio management skills
• 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 lead cross-functional teams and influence stakeholders in a matrix organization
• Ability to work in a fast-paced and dynamic environment and manage multiple programs simultaneously
• Strong analytical and problem-solving skills, with a focus on innovation, automation, and continuous improvement

Tech Stack

• Python
• SQL

Benefits

• Competitive remuneration packages
• Commitment to team member wellbeing