Job Summary
A biotech company is filling a position for a Remote Clinical Data and Reporting Standards Associate Director.
Core Responsibilities of this position include:
- Leading a cross-functional team of subject matter experts
- Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions
- Ensuring consistency across standard types
Position Requirements Include:
- Knowledge of CDSIC standards and their application in regulatory submissions
- Experience leading development of standards for ADaM, Analysis Results Metadata, and/or TLF standards
- Experience with creating Analysis Results Metadata and/or TLFs
- Experience with preparing ADaM datasets and documentation for regulatory submissions
- Experience with standards related to immunology, oncology, eye care, neuroscience, virology, etc
- MS with 10 years of clinical research experience, or BS with 12 years of clinical research experience
