Director Biostatistics: Infectious Diseases

Director of Biometrics - Infectious diseases.

Being part of a new team and reporting directly to the head of Biometrics you will recived project autonomy and be a part of the senior management team responsible of taking Biometrics and the organisation to the next level.

Currently standing at 2000 employees globally this organisation has seen 18% headcount growth, FDA approvals already in 2012.

Biometrics, has full responsibility for the management, oversight, operations,

and directions of all projects within a franchise/therapeutic area, and a group

of Biometrics staff working on those projects. The Director is responsible for

setting the technical directions for the group and is accountable for the

quality and timeliness of the group deliverables; he/she is responsible for

optimization of interdisciplinary understanding, teamwork, innovative and

strategic project planning for the group; is responsible for effective project

team operation and productive cross-functional collaboration of project teams

The director is also responsible for the development and implementation of

technical and strategic plans for effective Biometrics contribution to project

discussions on study design, conduct, and analysis, as well as regulatory

strategies at the Medicine Development Team (MDT) and Clinical Development Plan

Task Force (CDP TF) levels; he/shell is also responsible for career goal setting

Essential experience

Accompanied with 2 + years working exclusively within Infectious diseases you will require evidence of :

10+ years working in a clinical management / statistical Biometrics environment

Excellent people management skills

Project / programme management experience

Statistical background

Experience integrating with Data management, clinical trials and statistical teams.

Statistical analysis for clinical trials

Clinical trials data consolidation and collection

Clinical trial database design (as an individual contributor or managing the data team)

Excellent communication skills

Understand regulatory submission processes

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