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Senior Biostatistics Expert
1 month ago
We are seeking a highly skilled Senior Biostatistician to join our team at Everest Clinical Research Services Inc. in Markham, Ontario or remotely from Canada.
About the RoleThe successful candidate will lead efforts in resolving day-to-day work-related issues and problems, securing quality, improving efficiency, and productivity of statistical and programming operations. They will also lead assigned projects by applying project management skills, statistical, and programming techniques; achieve quality and on-time delivery of deliverables, earn clients' trust, and repeat business.
Key Responsibilities:- Provide statistical expertise for design, analysis, and reporting of clinical trials and research projects.
- Contribute to the writing of statistical sections of study protocols, perform sample size calculations, develop randomization specifications, and generate randomization codes.
- Write Statistical Analysis Plans (SAPs) and properly address Peer Statistician review comments.
- Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects.
- Provide input to unblinded data management plans when required.
- Assist in research and development of statistical methodologies and processes.
- Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required.
- Perform QC validation of analysis datasets and TLGs.
- Perform third-level review of dry runs and final run.
- Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions, and interacting with data management to follow up and resolve data issues.
- Review and provide input to the Analysis Data Reviewer's Guide, discuss and incorporate Data Standards Reviewer's review comments to ensure quality of the document.
A Ph.D. degree in statistical science, mathematical analysis, or related fields plus 2 years highly relevant experience or a Master's degree plus 4 years highly relevant experience, with demonstrated ability and sustained performance.
Estimated Salary:$90,000 - $120,000 per annum based on qualifications and location.
