Principal Statistical Programmer

The Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent will work closely with internal partnering functions, collaborators, and external functional service providers to ensure all the programming results are delivered in a timely manner with high quality.

In this role, a typical day might include the following:

1. Support and/or lead programmer for programming and QC of analysis datasets, TFLs or standard tools following Regeneron standard data models or user requirements.
2. Integration of data across studies in support of CSS/CSE. Build, lead and maintain the programming specifications for the analysis datasets applying Regeneron tools and methodologies.
3. Support creation and validation of submission requirements (i.e. annotated CRF, data export files, define documents).
4. 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. If applicable, develop and provide department training for applications and standard tools developed by the department functions group.

This role may be for you if you have:

1. Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc.
2. Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles). Knowledge of regulatory submissions and requirements is a plus.
3. SAS, (Base, Stat, Macro, graph); SAS certificates a plus.

To be considered for this opportunity you must have:

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.

Salary Range (annually): $106,200.00 - $173,200.00