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Senior / Principal Biostatistician - CRO - UK/Remote
We have recently partnered with this modern thinking, CRO, who are looking for biostatisticians to join their team, to expand their outreach in the UK / Europe.
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.
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.
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.
D. degree in statistical science, mathematical analysis or related fields
A Master’s degree in the above fields