Position Overview:
The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.
Responsibilities:
- Collaborating with Clinical Research, Regulatory Affairs, and Clinical Operations Expertise Areas to design clinical trials.
- Writing the statistical sections of clinical trial protocols, while consulting with internal and external experts.
- Contributing to or preparing statistical analysis plans.
- Collaborating with Data management, Clinical Research, and Clinical Operations on design of eCRFs.
- Providing statistical guidance on conduct of ongoing clinical trials.
- Collaborating with Statistical Programmers on summary and analysis of trial data.
- Managing CRO statistical and programming support.
Requirements:
- You have a PhD in Biostatistics, Statistics, or Equivalent with at least 5 years pharmaceutical biostatistics experience or MS with at least 8 years of relevant experience
- Excellent written and oral communication and presentation skills
- Experience programming in SAS
- Working knowledge of FDA, EMA, and ICH regulations and guidelines
- Familiarity with sample size software such as nQuery or EAST
- Experience with CDISC, including CDASH, SDTM, and ADaM
- Experience in oncology preferred
- Experience in NDAs, MAAs, or other regulatory submissions a plus
