Associate Director Statistical Programming (Oncology)
Mainz, Germany; London, United Kingdom; Munich, Germany; Paris, France; Randstad, Netherlands | full time | Job ID:8855
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 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
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.
Anticipate 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)
Provides 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
Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards
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
Strong analytical and problem-solving skills
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.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.