Job Description
Job Description
We are professionals proficient in designing experiments, particularly within the drug development industry. The design of experiments as it applies to clinical trial/studies is a scientific method undertaken to evaluate associations (relationships within data). Our specialty is on the application of statistical science to clinical experiments in phases 1-4.
- Perform duties of a Study Statistician to support clinical trials of all phases.
- Review work by programmers and programming plans.
- Experience with ADaM data sets is required.
- Contribute to clinical study reports and related activities.
- Prepare statistical analysis plans, specifications for analysis datasets, and table shells.
- Program in SAS (or R) to conduct analyses and to create presentation ready TLFs.
- Review and consult on CRF design and database edit checks.
- Communicate study level resource/quality issues that may impact deliverables or timelines.
- Participate in process improvement initiatives and the development of SOPs.
Requirements
- You are dedicated to continual learning.
- PhD in statistics/biostatistics with 1+ years of clinical trials experience (or MS with 3+ years).
- It’s attractive to be able to conduct simulation studies to evaluate operating characteristics of a statistical method (e.g., adaptive designs, interim analyses, Bayesian methods).
- At the core, you’re humble in your role as a teacher and a consultant to the study team.
- Able to work to strict timelines, including the possibility of urgent deliverables.