Our client is a premier, nationally recognized Pharmaceutical company looking to hire a Sr. Manager, Translational Science Biostatistics. The Senior Manager will be expected to work independently with minimal supervision, serving as the study statistician for clinical studies.
- Be responsible for the operational aspects of the groups in support of (typically, 1-2) clinical pharmacology studies
- PCS / Clinical Protocol Development reviews whole protocols and interfaces with clinical pharmacologists and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration, etc.
- Statistical Analysis Plan develops SAPs, TLG shells and specifications of variable derivation
- Monitoring develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed)
- Clinical Study Report provides statistical and validation support for analysis datasets, statistical tables, figures and listings performs and validates statistical analysis; independently reviews CSRs and performs data interpretation
The pharmaceutical industry is NJ's top industry and recession-proof. Very stable environment.
- PHD preferred
- Experience in clinical pharmacology, clinical development and/or biomarker development biostatistical methods and processes in industry setting required
- Pharmaceutical/Biotech industry required