Proclinical currently has a rare opportunity for an expert level lead statistician to join as a Principal Biostatistician II in the UK or mainland Europe. This organisation is a leading CRO with 100 offices worldwide and is dedicated to changing medicine.
- Provides expert knowledge and mentoring on statistical and regulatory issues, development/delivery of training, and implementation of best practices for the department.
- Serves as (or mentors) the lead statistician or project lead, overseeing multiple or large-scale projects, ensuring adherence to company SOPs and working practices.
- Serves as senior reviewer on simple or moderately complex studies as assigned with minimal oversight, and on more complex studies as assigned with supervision as needed.
- May serve in a project oversight role for studies to represent the study(s) to all functions as needed, and fully accountable for all aspects of the management of risk.
- Provides technical input/writing into study design and statistical considerations during protocol development or review, SAP development/review, and provides expert knowledge and experience of complex trials design across different therapeutic areas.
- As assigned, oversees the preparation and review of key submission deliverables such as CSRs, ISS, ISE, Reviewers Guides, etc.
- Provides input and assistance to management for activities such as hiring recommendations, department policy development/review/training, process improvement initiatives, etc.
- Leads/accountable for bidding and business development activities for standalone opportunities and contributes significantly to full-service bids/proposals/budget revision and defense strategies. Prepares for and represents the company at bid defenses.
Skills and Requirements
- Master degree in statistics, biostatistics, mathematics or related field with 7+ years experience
- Extensive experience of statistics in a clinical trial environment.
- Extensive project lead/PM experience, clearly demonstrated in previous positions
- Evidence of providing expert statistical input in previous positions and presenting at statistical conferences would be an advantage.
- Mastery of the statistical principles underlying clinical trials
- Mastery of the regulatory issues associated with the reporting of clinical data in the submission process
- Mastery of SAS® programming skills and familiarity of other statistical packages (eg StatXact, Nquery) and understanding of database structures
- Superb organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams on 02038543893 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.