A Sr. Manager Statistical Programming for System and Standards is responsible and accountable for managing SAS server access, SAS macro tools and standards, software applications for statistical programming in BDM department.
• Work with IT to maintain proper access control to SAS GRID server, secured data transfer port, and other relevant software/web applications
• Maintain and enhance report generation and validation SAS utility package
• Develop and maintain SAS macro library for statistical analysis and data display
• Leads and oversees all aspects of CDISC data standards, including specs, tool, process, and implementations
• Leads and oversees all aspects of electronic submission standards, tool, process, and implementations
• Mentor junior level staff in therapeutic area requirements
• 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
• Advises management on new standards, guidelines, and recommendations
Experience And Required Skills :
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.
• Works independently as well as collaboratively and as a supervisor
• Works in accordance with existing policies and standards for application to specific problems or task
• Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area
• Extensive understanding of relational databases and experience working with complex data systems
• Extensive experience in development and implementation of standardization methodology in at least one therapeutic area.
• 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
• 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.
• Experience in working on a submission to regulatory authorities
• Knowledge of regulatory requirements concerning electronic submission standards
• Experience in creation of current CDISC data structures
• Leadership experience, especially in the hiring, development, evaluation and support of junior staff and contractors.
• 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.
• Understand estimation of resource requirements
• SAS, (Base, Stat, Macro, graph) and S-Plus/R
May report to a Assoc. Director or above. Requires the ability to influence others to achieve results. May manage subordinate supervisors.