Associate Director, Statistical Programming

Role Summary

Associate Director, Statistical Programming located in Cambridge, GA, or New Jersey (US) for a full-time role. Primary responsibilities include leading statistical programming deliverables, managing internal and external programming resources, and ensuring regulatory-aligned outputs for clinical studies.

Responsibilities

• Work with Portfolio lead to implement global statistical programming strategies that enable successful project deliverables.
• Lead the statistical programming deliverables (e.g., SDTM/ADaM datasets, tables, listings, figures) for assigned studies, ensuring alignment with protocols, statistical analysis plans (SAPs), and timelines.
• Manage internal/FSP programmers or external vendors (CROs) to maintain quality, consistency, and compliance with CDISC standards and regulatory requirements.
• Provide hands-on review, validation, and troubleshooting of SAS/R programs for data transformation, analysis, and reporting. Ensure accuracy of efficacy/safety outputs, perform QC, and resolve discrepancies.
• Serve as the primary programming point of contact for study teams, collaborating with Biostatistics, Clinicals, and Regulatory Affairs to ensure delivery of submission-ready outputs.
• Oversee CRO partnership, including scope negotiation, timeline oversight, and quality monitoring and audits.
• Anticipate resource needs and manage allocation across studies to ensure balanced workload and timely deliverables.
• Develop and implement standard macros, tools, or workflows to improve efficiency across studies. Train junior programmers and CRO staff on BioNTech standards, best practices, and emerging regulatory guidance.
• Provide programming support to regulatory submissions including data submission package, define.xml, and CSR appendices.

Qualifications

Education

• Bachelor’s degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred

Experience

• 10+ years (5+ years for advanced degree) of statistical programming experience in pharmaceutical, CRO, or clinical research settings, with Oncology experience required
• Excellent knowledge of SAS (Base, Macro, STAT, GRAPH, SQL); working knowledge of R or Python a plus.
• Strong knowledge of regulatory requirements (FDA, EMA, ICH, and other global guidelines).
• Hands-on experience with industry data standards (CDISC SDTM, ADaM).
• Experience managing study-level programming deliverables and external CRO vendors oversight.
• Demonstrated project management skills with ability to coordinate multiple studies simultaneously