Senior Statistical Programmer

4 weeks ago


Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full time

Job Summary

The Senior Statistical Programmer will provide support to the lead programmer and study team on all programming activities according to the study requirements and timelines. This role contributes to studies in various therapeutic areas and all clinical trial phases.

Key Responsibilities

  • Implement and execute the programming and project standard under minimal supervision of the lead programmer and manager to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.
  • Maintain programming documentations such as study tracker, code, logs, and outputs in a regulated environment.
  • Support and/or lead programmer for programming and QC of analysis datasets, TFLs 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 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.
  • Provide programming support for simple presentations and basic statistical ad-hoc requests.
  • Assist in the more complex data presentations.

Requirements

  • Proficiency in SAS programming skills in a clinical data environment.
  • Knowledge of other programming languages such as R, Python etc. is a plus.
  • Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles).
  • Ability to work on global interdisciplinary teams.
  • Good organizational, interpersonal, and communication skills.
  • Positive attitude, team player and growth mindset.

Education

MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline with years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.

SAS Certification desirable.



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