Sajawo

Statistician

• 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.

Lead Clinical Statistician