Principal Biostatistician in England
Metric Bio is looking for an Principal Biostatistician in England
Job description
Our partner
A leading full-service contract research organization (CRO) is seeking a Senior Biostatistician to join its team. With a global presence and a strong foundation in statistical and data management, the company supports a range of clients in pharmaceutical, biotechnology, and medical device with their clinical development programs.
Your responsibilities
- Provide statistical expertise for the design, analysis, and reporting of clinical trials and research projects.
- Contribute to writing statistical sections of protocols, conduct sample size calculations, develop randomization specifications, and generate codes.
- Write Statistical Analysis Plans (SAPs) and address peer statistician feedback.
- Create and maintain Statistical and Programming Quality Control (QC) and Quality Assurance (QA) Plans.
- Provide input on unblinded data management plans where necessary.
- Support the development and refinement of statistical methodologies and internal processes.
- Perform statistical analyses according to the SAP and respond to QC review comments.
- Conduct statistical validation of key results and address additional review feedback.
- Contribute to trial result dissemination meetings and documentation.
- Assist with the statistical components of Clinical Study Reports (CSRs), including writing and reviewing for accuracy and interpretation.
- Conduct statistical analyses for abstracts, manuscripts, presentations, and posters.
- Develop and/or review ADaM dataset specifications; review SDTM specifications as needed.
- Perform QC validation of datasets and tables/listings/figures (TLGs).
- Conduct third-level reviews of dry and final runs.
- Lead statistical dry and final runs, manage resources, and collaborate with programming and data management teams.
- Provide input and respond to feedback for the Analysis Data Reviewer’s Guide.
- Offer statistical input on Case Report Forms (CRFs) and variable/database structure.
- Provide guidance for non-CRF data collection methods.
- Review Data Management Plans, focusing on critical data collection and cleaning.
- Define or program database quality checks, assess/report data issues, and track to resolution.
- Monitor data quality, including protocol deviations, and support data lock preparation.
- Lead resolution of operational challenges, ensuring quality and efficiency.
- Manage assigned projects using project management and statistical expertise to deliver high-quality results on time and foster client satisfaction.
- Follow internal policies, standard operating procedures (SOPs), and sponsor work instructions.
- Archive study documentation in line with sponsor requirements.
Requirements
- A Ph.D. Degree in statistical science, mathematical analysis from a top UK university
- 4+ years relevant biostatistical experience
- Proven ability within a clinical trial environment.
- Must come from a Contract Research Organisation
Extra information
- Status
- Open
- Education Level
- Secondary School
- Location
- England
- Type of Contract
- Part-time jobs
- Published at
- 09-07-2025
- Full UK/EU driving license preferred
- No
- Car Preferred
- No
- Must be eligible to work in the EU
- No
- Cover Letter Required
- No
- Languages
- English
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