Provide timely support to the study team on all programming matters according to the project strategies
Create initial TFLs list for CP report based study SAP and CP TFL standards
Lead programming support for processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan
Provides documentation and consistent maintenance of code, logs, and output in a regulated environment
Works independently to design and test program logic, coding programs, program documentation and preparation of programs
Lead/participate projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses
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 report
Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies
Lead and execute the creation and validation of electronic data submission packages according to CDISC standards

MS. (BS.) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry
Strong SAS programming skills (SAS (Base, Stat, Macro, graph) in a clinical data environment)
Good understanding of relational database structure
Understanding of 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
Experience in project management with supervision
Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel.
Skilled in use of relevant software, including Window SAS, SAS EG (Base, Stat, Macro, graph), MS-Excel, R/R-Studio etc.

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

Principal Pharmacometrics Programmer

Key skills