Principal Biostatistician FSP - Hybrid Model United Kingdom; Hybrid Posted Be

United Kingdom (Hybrid)

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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.

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.

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.

• Job Identification 1158
• Posting Date 12/05/2025, 08:32 PM
• Locations 6th Floor, 9 Appold Street, London, London, EC2A 2AP
  , GB (Hybrid)
• Job Schedule Full time

Cytel Inc. is an Equal Employment / Affi ... [EEO Statement]

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