Lead Clinical Statistician

This is a remote position.

We're looking for an experienced Lead Clinical Statistician to provide statistical leadership across our clinical development programmes. 

This is a highly visible role working alongside Clinical Development, Data Management, Statistical Programming, Medical Affairs and Regulatory teams to ensure robust statistical strategy from study design through to submission.

You'll act as the statistical lead across one or more clinical programmes, providing expert guidance on study methodology, protocol development, analysis planning and interpretation of results.

Key Responsibilities

• Lead statistical strategy across Phase I-IV clinical studies.
  
• Provide statistical input into clinical development plans, study design and protocol development.
  
• Design appropriate statistical methodologies and randomisation strategies.
  
• Author and review: SAPs, CSR, ISS, ISE.
  
• Review outputs from statistical programmers including TFLs, ADaM datasets and analysis deliverables.
  
• Interpret study results and communicate findings to clinical, scientific and executive stakeholders.
  
• Collaborate closely with Clinical Operations, Data Management, Medical Writing and Regulatory Affairs.
  
• Represent Statistics within cross-functional project teams.
  
• Provide oversight of external CROs and statistical vendors, ensuring quality, timelines and regulatory compliance.
  
• Contribute to regulatory submissions and support interactions with FDA, EMA and other health authorities.
  
• Ensure statistical deliverables comply with ICH, GCP and relevant regulatory guidance.
  
• Drive continuous improvement of statistical standards, processes and best practices.
  
• Mentor / lead statisticians.
  

Requirements

• Advanced knowledge of statistical methodology for clinical trials.
  
• Experience reviewing SAS or R outputs.
  
• Familiarity with Bayesian methods or adaptive designs desirable.
  
• Knowledge of survival analysis, mixed models and longitudinal data analysis.
  
• Experience interpreting complex clinical datasets.
  
• Understanding of real-world evidence and observational analyses is advantageous.
  

MSc or PhD in Statistics, Biostatistics, Mathematics or related quantitative discipline.

Experience within ideally fast paced biotech (or relevant Pharma / CRO).

Significant experience leading statistics for clinical development programmes.

Strong understanding of clinical trial methodology and adaptive study design.

Experience supporting regulatory submissions.

Excellent knowledge of:

• ICH E9
  
• CDISC standards (ADaM/SDTM)
  
• GCP
  
• FDA and EMA statistical guidance
  

Experience working with external CROs and vendors.

Strong communication and stakeholder management skills.

Benefits