Statistical Programmer Consultant

Working with the Biometrics staff, the Statistical Programmer Consultant provides programming support for Phase 1 to Phase 3 studies, including project integration and disease monitoring project work. Provides timely support to the project team on all statistical programming matters according to the project strategy.  Programs SDTM/ADaM/TLFs for the studies, write datasets specification, QC datasets and tables. Identifies and communicates changes in project requirements that may affect key deliverables.

Responsibilities

·       Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs

·       Creates and reviews annotated CRF to SDTM datasets

·       Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives

·       Functions as a positive role model for setting high expectations for quality, creativity and project ownership

·       Works collaboratively with Clinical Operations, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting

·       Provides technical input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers)

·       Works with Biometrics and other functions for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate

·       Involved with the strategy for process improvement

·       Identifies new tools to increase efficiency and quality

Requirements:

·        Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline

·       Minimum of 1-5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry

·       Advanced SAS programming skill s and experience in other statistical software, such as R and S-Plus

·       Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies

·       Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regards to statistical programming processes, management of statistical programing projects

·       Excellent organizational skills and ability to prioritize  tasks