Job Description
-Performs biostatistical and programming activities for given clinical trials involving drugs, biologics and medical devices.
-Responsible for all statistical tasks with a high level of independence e.g. clinical trial design/planning, sample size estimations, analysis plan, defining safety, efficacy and exploratory endpoints, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase .
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Within the context of biological product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices.
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Able to manage CRO deliverables.
- Follow processes and adhere to Health Authority requirements (SOP's, GCP and regulatory guidelines).Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/Global Clinical Trial Teams
-Responsible for all statistical tasks with a high level of independence e.g. clinical trial design/planning, sample size estimations, analysis plan, defining safety, efficacy and exploratory endpoints, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase .
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Within the context of biological product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices.
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Able to manage CRO deliverables.
- Follow processes and adhere to Health Authority requirements (SOP's, GCP and regulatory guidelines).Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/Global Clinical Trial Teams
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