An innovative Biopharm company is looking to add an AD/Director of Biostatistics to their Biometrics group due to rapid expansion. If you have experience working on Phase I-IV clinical trials in the Life Sciences industry, are a self-starter, and want to be a part of groundbreaking projects, this is the job for you.
The AD/Director of Biostatistics will serve as a functional statistical lead on clinical development projects. This role will work in conjunction with biostatisticians, data managers, and programmers within all phases of clinical studies.
Responsibilities:
- Manage multiple levels of personnel within the Biostatistics function to develop and execute statistical strategy, design, and analyses of clinical trials
- Management of CROs and their timelines for delivery of analysis
- Set standards and guidelines for CROs to ensure quality
- Work in conjunction with the department head, peer management, and employees to develop while following department standards and management
- Design of statistical methods
- Correspondance with regulatory agencies
- Work collaboratively in all stages of clinical trials
- Convey study results to internal and external groups
- Troubleshooting statistical methods
The Ideal candidate will have:
- PhD or Master's Degree in Statistics, Mathematics, or related fields
- 8+ years of experience in pharmaceutical or biotechnology industry is required
- Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials
- extensive knowledge of drug development regulations pertinent to the statistical analysis
- experience in contributing to NDAs/BLAs submission and defense preferred
- Proficient SAS programming skills, solid understanding of CDISC models and standards
- Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills