Principal Biostatistician

Principal Biostatistician

Permanent Role

Homebased Flexibility

Jonathan Cunliffe at Umbilical Life is shortlisting for a Principal Biostatistician to join a leading Pharmaceutical company.

I would like to speak to talented individuals who wish to be an integral part of an exciting team. For a confidential conversation call Jonathan Cunliffe on +49 3221 421 9777 or email Jonathan@umbilical-life.com.

Accountable for:

• Provide statistical input to the design, analysis, reporting and interpretation of clinical trials.
• Influencing clinical development plans, regulatory and commercial strategies.
• Identifying and implementing innovative statistical methodologies.
• Provide guidelines and standards to CROs to ensure quality of deliverables.
• Represent Biostatistics in meetings with project teams ensuring adherence to FDA/ICH guidelines, Good Clinical Practices, and regulatory requirements. 

Qualifications/ Requirements:

• Masters or PhD in a statistical field.
• 5+ years of experience within the Biometrics.
• Strong lead experience of both people and projects.
• Comprehensive knowledge of statistical methodology in design, analysis and regulatory requirements relating to clinical development of drugs.
• Expertise in designing clinical trials, including the development of study related documents (e.g. Statistical Analysis Plan, Statistical part of Study Protocols, Case Report Form, Data Management Plan, IDMC Charter).
• Profound knowledge of statistical software SAS.
• Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.