Senior Statistical Programmer

3 weeks ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Summary

The Senior Statistical Programmer provides support to the lead programmer and study team on all programming activities according to the study requirements and the timelines. This role contributes to studies in various therapeutic areas and all clinical trial phases. The incumbent implements and executes 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. Maintains programming documentations such as study tracker, code, logs, and outputs in a regulated environment.

Key Responsibilities
  • 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. If applicable, 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.
  • Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, and accountability.
  • Create and maintain the programming specification and other documentation in accordance with SOPs/Guidance/WI/process to ensure traceability and regulatory compliance.
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. (BS) 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.

About BioSpace, Inc.
BioSpace, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

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