Clinical Programmer

Position

Statistical Programmer, Manager

Direct Report

Director of Biostatistics

Position Summary

The Statistical Programmer is to support the Biostatistics team by maintaining the computing environment and contributing to the overall efficiency and best practice running of the Biostatistics systems. The Statistical Programmer should demonstrate the ability to work efficiently and to a high standard within a clinical team environment.

Key Responsibilities

  • Provide statistical programming support per requests from Biostatisticians and other functional areas such as medical/clinical or medical writing.
  • Develop, maintain, and validate SAS program/macros for study specific analysis or at the standard level.
  • Generate TFLs per table shells or ad hoc requests; perform validation to TFLs that generated by other programmers per table shells or ad hoc requests.
  • Attend internal or cross-functional meetings with inputs from Statistical Programming group.
  • Oversee and manage programming activities which may be conducted by external vendors.
  • Work with external vendors in order to develop or monitor the content and structure of SAS and related Software installations.
  • Develop and maintain SOPs, I-Mab Lifecycle Data Standards and other related technical documents, provide input and feedback.
  • Provide input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents and determining and researching SAS software upgrades and related system maintenance issues.
  • Write and Executing systems and macro testing, and deliver training.
  • Generate SDTM/ADaM datasets and associated specs files; perform validation to SDTM/ADaM datasets that generated by other programmers per specs files.

Ideal Background

  • Education: (minimum/desirable): bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline.
  • Languages: Fluent English (oral and written).
  • Experience/Professional requirement:
    • Experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
    • Experience in a pharmaceutical/CRO programming environment or demonstrated understanding of SAS programming activities in a clinical pharmaceutical/CRO environment.
    • Validation and Systems Development Life Cycle.
    • Experience using SAS-Base, MACRO, STAT, GRAPH, MS Office and R.
    • Understanding of regulatory guidelines.
    • Hands-on experience with industry tools including biostatistics platforms, ETL, standard reporting and visualization tools.