Senior Project Statistician
Ashley Clarke @ RBW consulting is currently recruiting for a Senior Statistician to work for a European CRO. They quality trial management multi-country trials. Their approach is very innovative and look for the same flare in their employees. They cover all phases of drug related trials, as well as clinical investigations for medical devices and diagnostic devices. The role is permanent and candidates must be based in Italy (Remote working possible but has to be still in Italy)
In collaboration with the Direct Manager, acts to achieve the Company goals, organizing independently the work in the area of interest, defining priorities and managing the loads originating from unexpected events. Contributes to the management and development of procedures relating to the activities in which is involved, ensuring that the activities of the whole Unit meet the quality standards required by the company. Manages the resources assigned optimizing timelines in order to ensure the effectiveness of work. Supervises the resources, verifying the formal and substantial coherence of the activities carried out, supporting their organization and defining priorities and timelines. Ensures the timely compilation of the systems for tracking activities and detecting by himself/herself and his/her resources. In carrying out the activities entrusted, guarantees compliance with rules, regulations and agreements on confidentiality and privacy, promptly reporting deviations. Defines the objectives to be assigned to the coordinated staff, collaborating with the Direct Manager in the final evaluation of the resources.
The project biostatistician reports to the Head of Biostatistics and is responsible to coordinate and supervise statistical activities across a diversified portfolio of clinical projects. The Biostatistics Coordinator also acts as a senior statistician for specific projects, ensuring statistical activities are managed in compliance with applicable standards, regulatory guidelines and SOPs. The Biostatistics Coordinator promotes the use of rigorous statistical methodologies, contributes to acquiring new associates and acts as a mentor for junior staff.
Collaborate with the Head of Biostatistics in coordinating and supervising the activities of the Statistical team;
- Ensure processes are correctly applied within the Statistical team; - Liaise with the study team, Sponsors and external stakeholders regarding statistical activities, study design and results of statistical analyses;
Defining the timeframes and costs of each project and preparing the biddings and invoices for the Sponsor; - Collaborate in establishing and maintaining document/programming standards; - Can act as a senior biostatistician in case of specific projects;
- Collaborate with Head of Biostatistics to establish and to maintain SOPs related to the Biostatistics Unit;
- Monitor updates in regulations and statistical methodology in clinical research applicable to activities and support related implementations;
- Present and share knowledge at team meetings; - Organize/perform trainings for project team and acts as a mentor for junior staff;
- Contribute to hiring and on-boarding of new associates.
Master Degree in Statistics (or equivalent degree) with a specialization in medical or epidemiological statistics;
- Several years 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.); - Project Management and problem-solving skills; - Excellent communication and team-working skills; - Strong commitment to quality;
- Proactive attitude and independence in organizing activities; - Flexibility and propensity for innovation; - English fluent; - Planning and organizational skills; - Leadership and communication skills; - Result-oriented; - Team-working oriented.
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
- Senior Director of Biostatistics
Job location: Job salary: £200000 to £255000
Overview The Senior Director, Biostatistics wi...
- Regulatory Affairs Senior Manager
Job location: Job salary: £750000 to £85000
My client is a large biotech company who are lo...
- R&D Lab Manager
Job location: Dublin Job salary: £40000 to £45000
My client is a clinical stage biopharmaceutical...