Director Statistical Programming
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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 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, 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 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 • Strong analytical, project management, and problem-solving skills • Ability to work in a fast-paced and dynamic environment • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for?
Responsibilities
• 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., AI/ML) to enhance programming efficiency • Develop standardized processes and mentor teams 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; t his 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 BioNTech’s global clinical initiatives that enhances its clinical operation, data analysis, and overall efficiency infrastructure of the statistical programming environment.