Principal Biostatistician FSP

1 day ago

London, Greater London, United Kingdom Cytel Full time £72,000 - £144,000 per year
Description

As Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on multiple therapeutic area with a focus on Rare Disease. 

Responsibilities

You will contribute by:

  • Providing statistical support to clinical studies, with a focus on Rare Disease;
  • 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.
Qualifications

What we're looking for:

  • Master's degree in statistics or a related discipline. PhD strongly desired.
  • 8+ 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, like longitudinal data analyses, missing data imputations, Survival analyses, etc. 
  • 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 is preferred.
  • Experience working with cross-functional teams and represent stat group.
  • 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.

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