Job Description:
• 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:
• Great benefits package on offer.