Senior or Principal Biostatistician
- Experience Level
- Experienced (non-manager)
Jonathan Cunliffe at Umbilical Life is shortlisting for a Principal Biostatistician to join an established Pharmaceutical based in Germany.
I would like to speak to experienced Statisticians looking to gain more experience across the entire development programme in various therapy areas and Oncology being one.
- Provide statistical input to the design, analysis, reporting and interpretation global development programs.
- 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.
- Defending the statistical approach at regulatory agencies such as EMA, FDA, PMDA.
- 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.
- 6+ years clinical trial statistics experience in Pharma or CRO environment.
- 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).
- Knowledge of statistical software SAS or R
- Special knowledge in multiple testing procedures, time-to-event methods, adaptive clinical trials and pharmacometrics
- Knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.