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Senior Biostatistician

Metric Bio
Newcastle upon Tyne
2 months ago
Applications closed

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A leading full-service contract research organization (CRO) is seeking a Senior Biostatisticianto 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 or related fields
  • 3+ years relevant biostatistical experience
  • Proven ability within a clinical trial environment.

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