Job Details

Oncology Statistician

Philadelphia, Philadelphia County, United Kingdom, Permanent

Posted: 23days ago


*Principal Biostatistician *

Permanent Role

Homebased Flexibility

Jonathan Cunliffe at Umbilical Life is shortlisting for a Principal Biostatistician to join a leading Pharmaceutical company and their innovative Oncology group.

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 .

[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.

* 1 year experience if holding a PhD or 3+ years if MSc in clinical trial statistics.

* 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

* Knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.

Job Details

Thu, 04 Mar 2021 09:34:00 EST
Philadelphia, Philadelphia County, United Kingdom