Job Category: Clinical: Data Management
Job Number: 2673
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. This will become an onsite position reporting to the Senior Director, Biostatistics.
How you will spend your day:
- 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.
- Contributing to clinical study reports and other regulatory documents, e.g. DSURs, Briefing Documents, etc.
- Contributing to scientific articles, summarizing data collected in company’ s clinical trials.
- Participating in other activities and meetings to support Biostatistics and the Development Team as needed.
- Consulting with Research & Preclinical colleagues on statistical questions in their work.
- Managing CRO statistical and programming support.
Requirements / Qualifications:
- 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