Statistical Programmer, Germany
The Statistical Programmer takes on the responsibility for biostatistical activities of those clinical trial projects assigned to him/her under consideration of the regulatory requirements, ICH and other international guidelines as well as the sponsor's and/or company instructions as stipulated in the contract of services. Good knowledge of German and English required.
Responsibilities
The Statistical Programmer takes on the responsibility for biostatistical activities of those clinical trial projects assigned to him/her under consideration of the regulatory requirements, ICH and other international guidelines as well as the sponsor's and/or company instructions as stipulated in the contract of services. Good knowledge of German and English required.
Responsibilities
- To support the generation and review of the procedures, guidelines, manuals and/or other documents applicable to the general or project-related biostatistical activities. Specifically, to generate, evaluate and validate SAS programmes as required within the evaluation process. This also includes to perform plausibility checks and other quality control actions in biostatistical areas, and to generate tables, lists, diagrams and other data presentation tools as requested by sponsor and/or company directives.
- To provide biostatistical information and assistance within the company. Upon previous authorisation or request of the line manager and if required, of the sponsor, to contact external parties in respect to biostatistical activities.
- To participate and support the organisation of company, department, and if required, project-related meetings. This includes supporting, informing, and participating in discussions during audits and inspections which include biostatistical activities. Additionally, to participate in meetings and other events at sponsor's and authorities locations, research institutions and other organisations in the scope of biostatistical activities.
- To report to the line manager on the biostatistical activities. This activity includes to generate, review, update, submit and archive these reports as required.
- If requested, to support the creation of a biostatistical team, as well as the set-up and evaluation of the methodology applicable to each project. Additionally, to support the control of timelines of each project, and to implement actions in case of problems.
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