Director of Biostats
Basking Ridge, NJ 07920
Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems.
- Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR):
Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.
- Expert knowledge of drug development and statistical methodologies.
- Excellent programming skills in SAS and/or R.
- Excellent oral and written communication skills.
- Working knowledge of statistical software package such as NQUERY, EAST, etc.
- Excellent Project planning skills.
- Demonstrated expertise in trial design and data analysis.
- Excellent collaborating skills.