Senior Statistical Programmer

Location
Basking Ridge, NJ, United States
Posted
Nov 19, 2020
Ref
21645BR
Required Education
Masters Degree/MBA
Position Type
Full time
Regeneron Pharmaceuticals, Inc. is seeking a Senior Statistical Programmer for our Basking Ridge, NJ location. Responsible for providing timely support to the study team on all programming matters according to the project strategies. Responsible for programming and QC of analysis datasets, TFL's or standard tools following Regeneron standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and milestones. Integration of data across studies in support of CSS/CSE. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies. Support creation and validation of e-submission requirements (i.e. annotated CRF, data export files, define documents). 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. Develop and provide department training for applications and standard tools developed by the department functions group. Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations. Participate in department working groups; provide input in development of tools and improvement of processes. Assist with projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses.

Qualified applicants will have a Master's degree in Clinical Research, Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field, and 4 years of experience in processing clinical trial data in a biotechnology, pharmaceutical, or health-related industry. In the alternative, employer will accept a Bachelor's degree in stated fields, and 7 years of programming experience in processing clinical trial data in a biotechnology, pharmaceutical, or health-related industry. Must have 4 years of experience with: relational database structure; reporting systems utilizing multiple data delivery applications; implementing standardization methodology; pharmaceutical clinical development including adhering to safety deliverables and performing efficacy analysis; providing programming support needs for BLA and other regulatory submissions; project management; development and execution of user requirements, validation plans, and operational and performance protocols; and creation of current CDISC data structures, including SAS, Base, Stat, Macro, and graph.

To apply, please mail resume to Chad Barney, Regeneron Pharmaceuticals, 777 Old Saw Mill River Rd, Tarrytown, NY 10591. Please reference requisition code 21645BR when applying. #LI-DNI, #GD-DNI, #IN-DNI