Job Summary
A global biopharmaceutical company has a current position open for a Remote Biostatistics Associate Director.
Individual must be able to fulfill the following responsibilities:
- Ensuring accurate, statistically valid deliverables
- Coordinating achievement of major statistical deliverables and milestones in collaboration with other functions
- Leveraging standardization to maximize global data integration and interpretability
Qualifications for this position include:
- Comprehensive knowledge of statistical methodology in design and analysis of clinical trial
- Regulatory requirements relating to clinical development of drugs and biologics
- BLA/NDA experience including eCTD submissions
- Working knowledge of major statistical software programs
- Knowledge of CDISC requirements for SDTM and ADaM
- Excellent verbal and written communication skills, and excellent inter-personal skills.
