Job Description

Who Are You?

A Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support 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 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:

As a Biostatistician, you'll 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.


ShortDescriptionStr
Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.



Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:


Master's degree in statistics or a related discipline. Ph.D. strongly desired. 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Oncology experience Experience working on integrated/pooled analyses (e.g. ISS/ISE) Experience working for a CRO is strongly desired. 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 is a plus. Solid understanding & implementation of CDISC requirements for regulatory submissions. Adept in ADaM specifications generation and QC of datasets. The ability to build strong external & internal relationships and motivate a regional or global team. Effective communicator: able to explain methodology and consequences of decisions in lay terms. InternalQualificationsStr

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:


Master's degree in statistics or a related discipline. Ph.D. strongly desired. 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Oncology experience Experience working on integrated/pooled analyses (e.g. ISS/ISE) Experience working for a CRO is strongly desired. 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 is a plus. Solid understanding & implementation of CDISC requirements for regulatory submissions. Adept in ADaM specifications generation and QC of datasets. The ability to build strong external & internal relationships and motivate a regional or global team. Effective communicator: able to explain methodology and consequences of decisions in lay terms. InternalResponsibilitiesStr

As a 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. ExternalResponsibilitiesStr

As a 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.