Principal Statistician

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead and provide statistical support for clinical research studies.

• Serve as the principal statistician for designated studies, managing statistical strategies and deliverables.

• Author and review Statistical Analysis Plans (SAPs), Analysis Database Specifications (ADS), and statistical components of clinical study reports.

• Review and interpret analysis outputs to ensure accuracy, quality, and compliance with regulations.

• Collaborate with Clinical, Programming, Data Management, and Regulatory teams.

• Offer guidance and oversight to statistical programmers as necessary.

• Communicate statistical concepts, results, and associated risks to both technical and non-technical stakeholders.

• Ensure compliance with FDA, ICH, GCP, and company SOP standards.

⛳️ Requirements

• MS or PhD in Statistics, Biostatistics, or a related discipline.

• No specific therapeutic area experience is required; familiarity with Oncology, Rare Disease, or Neuroscience is a plus.

• Excellent oral and written communication skills.

• Understanding of statistics, the drug development process, and pertinent FDA regulations.

• Experience in the pharmaceutical, CRO, or related industry involving clinical trials.

• Proven experience interacting with Regulatory Agencies, particularly the FDA.

🏝️ Benefits

• Opportunities for professional growth.

• A fulfilling and rewarding career.

• Ongoing training and development programs.

• Commitment to equal opportunity, diversity, and inclusivity.

• Permanent employment status.