at Cytel in Boise, Idaho, United States Job Description Who Are You? An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

Our Senior Biostatisticians perform ad-hoc or exploratory analyses to support submission or Health Authority Questions. Having exposure to regulatory work experience is a bonus, for example, if you understand the regulatory questions and translating them to statistical problems, collaborating effectively, with clinical and regulatory colleagues. Supporting medium complexity clinical trials (starting from Design to Archival experience) and supporting some project-level activities. As a Senior Biostatistician, your responsibilities will include:

+ Providing statistical support to clinical studies

+ 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 and interpreting statistical results

+ Preparing clinical study reports, including integrated summaries for submissions

+ Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.

+ Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.

+ Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros

+ Participate in the development of CRFs, edit check specifications, a To view full details and how to apply, please login or create a Job Seeker account