Senior/Principal Biostatistician FSP

Senior/Principal Biostatistician FSP

Cytel

Remote

Responsibilities

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.

Qualifications

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.