Provide timely support to the study team on all programming matters
Provides project leadership, resource planning/coordinating deliverables within project or across multiple projects
Lead programming support for processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan
Provide programming support for all PMX deliverable in HAR request, data driven analysis, publications, conference
Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports
Requirements
Master in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline
10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry
Expert SAS programming skills (SAS (Base, Stat, Macro, graph) in a clinical data environment
Understanding of relational database structure and reporting systems utilizing multiple data delivery applications
Strong Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards
Comprehensive understanding of biostatistics, pharmaceutical clinical development (i.e. safety deliverables, efficacy analysis)
Experienced in data handling, process and analysis and able to understand/perform Pharmacokinetics, immunogenicity, exposure response analysis in timely manner
Mentor junior level staff in therapeutic area requirements
Develop collaborative work environment and be a positive role model.
Good Skilled in use of relevant software, including Window SAS, SAS studio (Base, Stat, Macro, graph), MS-Excel, R programming and/or Python.
Good knowledges in AI use case in statistical programming and data sciences.