Penfield Search Partners
Our client is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies that treat unmet medical needs across several indications and therapeutic areas. They are seeking an Associate Director, Biostatistics to support efforts in this developing area.
What you will do:
- Provide statistical expertise and input to drug development programs including the design of clinical studies and analyses requiring advanced statistical methodologies
- Recognize and address issues which may affect the statistical integrity of the development program or for which statistical tools may add value
- Perform vendor oversight
- Provide statistical input into the preparation of marketing applications (NDA/BLA) to regulatory agencies.
- Develop and review SAPs, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports
- Provide input into publication planning, and ensure timely execution of analyses
- Collaborate cross-functionally to develop standards for building databases, edit checks, and statistical programming for data analyses.
- Collaborate with project team members regarding signal detection and safety surveillance techniques
- Support internal exploratory analyses with previous or ongoing in-house trial data
Desired for this role:
- MS or PhD in Biostatistics
- 5+ years industry experience in clinical and drug development experience
- Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development
- Working knowledge of SAS
- Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in drug development, staying current with developments in these fields
- Flexibility to changing priorities, being detail-oriented, and the ability to take on unfamiliar tasks