Senior Project Biostatistician

Project Statistician

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 can be based in the UK or Europe

Job Profile

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.

Qualifications

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.