This position is for qualified statistical programmer with experience in the pharmaceutical or biotechnology sector, to collaborate in cross-functional drug development teams to develop and support innovative statistical analysis for the development of strategy and analysis of clinical trial studies.
The incumbent will provide his/her statistical programming experience and expertise to support project statisticians on analysis across multiple assigned projects, on innovative statistics methodologies or clinical trial designs for drug discovery, on preparation of presentations at management and team meetings, and on various publications.
The incumbent is responsible for leading the programming aspect of the project for all programming deliverables and participates in the identification and implementation of programming standards and macros to facilitate the creation of statistical deliverables.
• Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming on projects using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Manage and coordinate programming following Regeneron standards.
• Implement and advise project statisticians on the use of department standardization tools when programming clinical data or system application deliverables.
• Contribute to programming development and quality control of the programming deliverables utilizing Regeneron tools and methodologies.
• Represent programming on the development and exploratory projects in a multidisciplinary project team to ensure timely and quality support for analysis and reporting.
• Contribute to develop data models, programming standards, and training.
• Provide mentor to junior level staff in programming group.
• Develop collaborative work environment and be a positive role model
• Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group.
Education and Experience:
Master's Degree & 10+ years
Also acceptable – MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry, including history of successful project and people management, and expertise in one or more therapeutic areas. SAS Certification desirable.
o Works independently as well as collaboratively. Works in accordance with existing policies and standards for application to specific problems or tasks.
o Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area.
o Extensive understanding of relational databases and experience working with complex data systems.
o Extensive experience in development and implementation of standardization methodology in at least one therapeutic area.
o Role model for demonstrating collaborative teamwork. Strong interpersonal skills that demonstrate initiative and motivation. Strong problem solving skills. Excellent verbal and written communication skills in a global environment.
o Experience in pharmaceutical clinical development in at least one therapeutic area (i.e. understanding of statistical concepts, techniques and clinical trial principles) and ability to provide programming support and leadership for BLA and other regulatory submissions.
o Experience in working on a submission to regulatory authorities.
o Knowledge of regulatory requirements concerning electronic submission standards.
o Experience in creation of current CDISC data structures.
o Leadership experience, especially in the hiring, development, evaluation and support of junior staff and contractors.
o Demonstrates ability to effectively organize and manage multiple assignments with challenging timelines and to identify areas for improvement in workflow and tool development to facilitate the process.
o Understand estimation of resource requirements.
Required Special Equipment and/or Programs:
SAS, (Base, Stat, Macro, graph) and S-Plus/R.