- Experience Level
- Experienced (non-manager)
As Senior Biostatisticians, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies, with a focus on Neurological Disorders
You will contribute by:
- providing statistical support to clinical studies, with a focus on Neurological Disorders (Multiple Sclerosis, HIV, Alzheimer’s, Strokes, etc.);
- participating in the development of study protocols, including participation in study design discussions and sample size calculations;
- reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
- performing statistical analyses;
- interpreting statistical results;
- preparing clinical study reports, including integrated summaries for submissions;
- leading study activities when called upon;
- utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
- serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
- being adaptable and flexible when priorities change
What we’re looking for:
- Master’s degree in statistics or a related discipline. PhD strongly desired.
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
- Knowledge and implementation of advanced statistical methods.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
- Strong knowledge of ICH guidelines.
- Solid understanding & implementation of CDISC requirement for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets.
- Submissions experience
- 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
What’s in it for you:
- You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
- You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
- Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
- Work with and leverage the best and brightest minds in the industry
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