Job Details
Senior / Principal Biostatistician
5856
Posted: 14/07/2025
- £Competitive
- Home Based, , United Kingdom
- Permanent
Senior / Principal Biostatistician | Independent CRO | UK - Home based |
Join a fast-growing, independent CRO providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries
Renowned for its high-quality deliverables, exceptional customer service, and flexibility in meeting clients’ needs this growing organisation offers a flexible, dynamic, and entrepreneurial culture. With ongoing growth and exciting career opportunities, it’s the perfect place to advance your career.
We’re seeking several Senior & Principal Statisticians to join this growing organisation remotely from anywhere in the UK.
Key Accountabilities:
Interested? Drop me a message or send your CV to jo@warmanobrien.com receive more details surrounding this role and discuss this further!
Join a fast-growing, independent CRO providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries
Renowned for its high-quality deliverables, exceptional customer service, and flexibility in meeting clients’ needs this growing organisation offers a flexible, dynamic, and entrepreneurial culture. With ongoing growth and exciting career opportunities, it’s the perfect place to advance your career.
We’re seeking several Senior & Principal Statisticians to join this growing organisation remotely from anywhere in the UK.
Key Accountabilities:
- Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects.
- Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting.
- Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects.
- Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.
- Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan.
- Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others.
- Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements.
- Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians
- Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians.
- Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.
- Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements
- Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectation (e.g., CDISC).
- Perform statistical and programming resource management, capacity analysis, benchmarking and metrics.
- Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.
- A Ph.D. degree in statistical science, mathematical analysis or related fields
- OR
- A Master’s degree in the above fields
- Work for a Global CRO and be a part for the expansion into Europe.
- Competitive salary + bonus.
- Eligible for medical, dental, vision, extended health benefits, pension, fitness subsidy & life insurance.
- Fully home based in the UK.
Interested? Drop me a message or send your CV to jo@warmanobrien.com receive more details surrounding this role and discuss this further!
Jo Fornaciari
Principal Consultant in Statistical Programming
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