- Experience Level
- Experienced (non-manager)
Cytel’s FSP group is growing and hiring well-rounded Principal Biostatisticians to provide statistical support, with a focus on ad-hoc work for clinical studies, and some publications support, across a variety of therapeutic areas.
You will participate in the development of study protocols including participation in study design discussions and sample size calculations, and review CRFs and data review guidelines.
Additionally, you will:
- Develop statistical analysis plans (SAPs) including analysis dataset and TLG specifications
- Perform statistical analyses
- Interpret statistical results
- Help prepare clinical study reports including integrated summaries for submissions
What we need from you:
- MS or PhD in a science or industry-related discipline with five or more (8+) years working on clinical trials.
- Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers.
- Knowledge of R programming a plus.
- Adept in ADaM specifications, generation and QC of datasets.
- Submissions experience strongly desired.
- Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- Team player; willingness to go the extra distance to get results, meet deadlines, etc.
- Ability to be flexible when priorities change and deal with ambiguity.
- Simulation and protocol design experience strongly desired.
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