- Contract Type
Jonathan Cunliffe at Umbilical Life is shortlisting for a Senior 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.
- 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.
- Masters or PhD in a statistical field.
- 3+ years of experience within the Biometrics.
- 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.
For a confidential discussion please contact
Jonathan Cunliffe at Umbilical on
+49 3221 421 9777 or email Jonathan@umbilical-life.com