Senior Statistician
- Employer
- Proclinical Staffing
- Location
- Poland / Madrid, Spain
- Salary
- Negotiable
- Start date
- 17 May 2021
- Closing date
- 16 Jun 2021
View more
- Discipline
- Data Management / Statistics, Biostatistics
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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. Job Responsibilities- 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.
- 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
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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