Exciting opportunity for a Clinical Statistician to work as a project/study statistician in multi-functional teams to provide support on clinical trial design, analysis and reporting.
Works as project/study statistician in multi-functional project teams. Main responsibilities include:
Provides statistical input in study design, analysis and reporting.
Contributes to the development of study synopsis, protocol, (e)CRF design, study report and publications. Co-ordinates and contributes to the development of statistical analysis plan and statistical report. Performs or co-ordinates exploratory analysis as needed.
Represents the statistics function in multifunctional project teams to ensure statistics-related activities conducted by the project teams and CROs are consistent with statistics SOPs, guidelines and standards.
Participates in the evaluation and selection of external vendors. Provides oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs from the study start-up through archiving. Reviews and validates statistics related CRO deliverables
Contributes to the development and implementation of the internal/departmental standards and process improvements.
Commit to their own professional development by attending regular training and conferences, keeping up to date with the latest industry techniques and regulations
Provides training to MPE employees.
Experience and Qualifications:
· An Msc or a PhD or equivalent in biostatistics, statistics or mathematics.
· Experience as a statistician within a Pharmaceutical company, a Biotech or a CRO.
· Good understanding of clinical study designs, statistical inferences and commonly used statistical methodologies.
· Good knowledge of EMEA/FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
· Comprehensive knowledge of the pharmaceutical industry including understanding of clinical drug development process and GCP requirements
· Good skill of statistical programming languages including SAS
· Good project management skills
· Excellent communication skills and ability to work with cross-functional teams
· Excellent knowledge of clinical quality standards
· Rebecca Bray – Talent Acquisition Specialist
· Tel: 020 8560 2300 for a confidential discussion
· Or send your CV quoting job ref AS 5347 to [log in to unmask]
· AXESS Limited, Parkshot House, 5 Kew Road, Richmond, Surrey, TW9 2PR
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