Scientific Director (Remote)

The Scientific Director reports to the C.E.O. and has the overall responsibility for providing scientific and strategic leadership to the Company clients for the successful planning, execution, and reporting of clinical studies. Plans and supervises all the activities of the Biometrics Department, including allocation of resources, defining the roles and responsibilities of the Biometrics Department personnel, together with the Head of Data Management Unit and the Head of Biostatistics Unit. 

Specific Tasks

 Be a scientific expert and the point of reference in statistical methods, regulatory guidelines, clinical study design and conduct; - Ensure that data management and statistical activities meet scientific, regulatory and quality requirements; -Ensure compliance to established processes/guidelines and qualitative standards; - Plan and supervise all the activities of the Biometrics Department, including allocation of resources; - Define the roles and responsibilities of the Biometrics Department personnel, together with the Head of Data Management Unit and the Head of Biostatistics Unit; - Ensure that the interfaces between Biometrics and other departments are managed optimally; - Establish and maintain contacts with Sponsor representatives on matters related to data management and statistics;

Requirements

Master Degree in statistics or scientific fields with a specialization in medical or epidemiological statistics;

- At least 10 years of work experience in the field;

- In depth knowledge of drug development process, epidemiology and HA guidelines;

- Continuing education and in-depth knowledge concerning data management and statistical methodology;

- Solid knowledge of CDISC standards (SDTM, ADaM);

- Able to plan, manage and oversee all activities of the Biometrics department;