Biostatistician II FSP

Job Description

As a Biostatistician II, 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. 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. 3+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. 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. As a Biostatistician II, 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.