Principal Biostatistician FSP

Cytel

London, United Kingdom

Job 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.