A leading and global Clinical Research Organisation is currently recruiting for a Senior Statistician to join their team based in Spain and Poland. They cover extensive clinical trials, which you are expected to lead. If you're a professional looking to further develop your statistical career, then this might be the role for you.
- Is responsible for all statistical activities regarding the assigned clinical studies, e.g. study design, sample size estimation, analysis plan, statistical analyses and reporting
- Work independently with minimal support from the Head of Biostatistics Unit
- Contribute to the design of clinical studies providing appropriate statistical methodology
- Review the study objectives and endpoints with the study team and or the Sponsor and write detailed statistical analysis plan (SAP)
- Generate randomisation lists or random selection procedures and collaborate with the Data Manager to produce the related documentation
- Collaborate with the Data Management team to design review the study CRF, to define protocol deviations, edit checks and other data quality controls
- Develop SAS programs and or collaborate with the SAS programmer to generate analysis, datasets, mock shells, TFLs for reporting and publications
- Perform the quality control of deliverables generated by other statisticians or SAS programmers
- Write the Statistical Report and/or the statistical sections of the Clinical Study Report
- Track activities and milestones to ensure timely project deliverables
- Liaise with Sponsor and external stakeholders regarding statistical activities and results of statistical analyses
- Collaborate in establishing and maintaining SOPs related to Biostatistics
- Organise trainings for project team and acts as a mentor for junior staff.
Skills and Requirements
- Degree in Statistics (or equivalent degree) with a specialisation in medical or epidemiological statistics
- At least 3 year of experience in CRO, biotech, pharma, research institutes or similar
- Proven knowledge and expertise in statistics and its applications to clinical research
- Solid knowledge and experience in drug development process and GCP guidelines
- Solid knowledge of SAS and other statistical software packages
- Experience in developing CDISC standard specifications and datasets (SDTM, ADaM)
- Knowledge of computer systems related to clinical trials (EDC, IVRS, IWRDS, EPRO, CTMS, etc.)
- Excellent communication and team-working skills
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