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Statistician with a Sound Understanding of Bioanalytical and Regulatory Processes Used in Immunoassay
Applies appropriate statistical methods to immunoassay data in accordance with GxP expectations, regulatory guidance, and study requirements, with support from the Senior Statistician where required.
Responsibilities
- Provides support for LC-MS and immunoassay data management requests, including sample storage period calculations, sample reconciliation requests, and formatting data to agreed specifications. This requires competent use of systems and software including LIMS, Excel, SAS, and WinNonlin.
Description
- Demonstrate a sound understanding of statistics and perform statistical analysis to the appropriate GxP standards and latest regulatory guidelines
- Deliver high-quality statistical analysis on method validation and sample analysis data, producing statistical reports and output and data files to required timelines using the appropriate specialist software
- Deliver data management activities in support of LC-MS and immunoassay departments where required, such as sample reconciliation requests and the formatting of data to appropriate specifications
- QC check statistical analysis, reports, and data files ensuring consistency with source data, data transfer agreements, plans, and other study documentation
- Write, QC check, and maintain scripts and template code
- Clearly communicate the outcome of statistical analysis to Operational staff and Sponsors, and provide advice on experimental design and approaches to statistical analysis
- Maintain an awareness of sponsor requirements and ensure that work aligns with Sponsor expectations
- Complete all required documentation accurately, on time, and in compliance with data integrity and good record-keeping principles
- Respond positively to changing timelines, priorities, and requirements, adapting workload and communication to support delivery.
- Proactively manage day-to-day priorities and complete agreed activities promptly, escalating conflicts or risks to timelines where appropriate.
- Participate actively in team scheduling meetings and maintain awareness of workload and status of active and upcoming projects
- Be familiar with, and work in accordance with, SOPs and Study Documents
- Communicate effectively across the organization
- Foster a collaborative, respectful, and inclusive working environment through positive interactions with colleagues
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Other Specific Responsibilities
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- Maintain an awareness of the proposal preparation and review process
- Make suggestions on process improvement
- Apply and maintain an awareness of current Data Management standards including SDTM/SEND and the implication of these in day-to-day work
- Prepare and review routine Sponsor-facing communications and documentation
- Take an interest in your own personal development, seek out training, and look for opportunities to grow
- Participate in teleconferences or meetings with the Sponsor, such as verbal input, presentation, or meeting minutes
- Work with QA to address audit findings, for which you are responsible, with minimal input from the SD/PI/APM, Team Leader/Senior Statistician/Senior Data Manager
- Be willing to contribute to publications and presentations when the opportunity becomes available
- Assists Team Leader/Senior Statistician/Senior Data Manager, with preparation of statistics and data management training materials for staff
- Look for opportunities outside of your core role. Contribute and participate without effecting your day-to-day responsibilities
Skills, Education & Qualifications
- A qualification in statistics or a related discipline is preferred, or previous relevant experience.
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Skills
Statistics
Data Management
Immunoassay
LC-MS
SAS
Excel
WinNonlin
GxP Standards
Regulatory Guidance
Sample Reconciliation
Statistical Analysis
QC Checking
Communication
Collaboration
Process Improvement
Training
Location