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BioNTech SE
Statistician as Director (m/f/d)
• Mainz, 55131
Führungs-/ Leitungspositionen Homeoffice möglich
Director Statistical Programming (Oncology) London, United Kingdom; Mainz, Germany; Munich, Germany; Paris, France; Randstad, Netherlands full time Job ID:8854 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 Align programming strategies with compound/platform objectives and regulatory requirements (e. g. , CDISC standards, FDA/ EMA guidelines) Drive the creation, review, and validation of SAS/ R programs for clinical data analysis, including SDTM/ ADaM datasets, efficacy/
safety outputs, and integrated summaries Ensure adherence to SOPs, regulatory standards, and reproducibility 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 Represent programming in clinical study team and other key meetings (e. g. , protocol reviews, submission readiness) Lead the programming contribution to global regulatory submissions (e. g. , NDAs, BLAs, MAAs) , ensuring compliance with eCTD requirements Manage the production of submission-ready datasets, TLFs, and documentation (e. g. , define. xml, reviewers guides) Champion the adoption of advanced analytics, automation tools (e. g. , SAS macros, Python) , and new technologies (e. g. [...] on emerging industry trends (e. g. , RWE, decentralized trials) Develop and establish efficient processes, innovative solutions, and standards to enhance the delivery of statistical analysis and reporting; this may include optimizing work flow and infrastructure of the statistical programming
environment, and also author relevant Standard Operating Procedures (SOP) to document and communicate these processes Actively participate in continuous improvement activities and processes reengineering to contribute to BioNTechs global clinical initiatives that enhances its clinical operation, data analysis, and overall efficiency infrastructure of the statistical programming environment Bachelors degree in Statistics, Mathematics, Computer Science or related discipline, advanced degree preferred15+ 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 Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, [...]
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