Principal Biostatistician

Date: Sep 13, 2022

Location: US

Company: Cytel Software Corporation

As Principal Biostatistician, adapt 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