Ashley Clarke @ RBW consulting is currently recruiting for a Principal Statistician to work remotely on a permanent basis in either UK or Europe.
My client provides a wealth of research knowledge for both biostatistics and operations in the life sciences industries for both software and services. They believe in investing their employees careers with significant professional growth and training. Their motivated staff is the biggest reason to their success.
As an Principal Biostatistician, you will leverage your knowledge and experience in applying advanced statistical methods and SAS skills to lead or help drive one or more Phase I-IV trials, with a focus on Oncology and Infectious Disease 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;
· interpreting statistical results;
· preparing clinical study reports, including integrated summaries for submissions (ISS/ISE);
· 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
· Master’s degree in statistics or a related discipline. PhD strongly desired.
· Experience in Medical Affairs, Oncology, Immunology or Cardiovascular 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 programmatic review of datasets.
· Submissions experience (ISS/ISE) strongly desired.
· 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
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
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