Senior Biostatistician, Germany
The Senior Biostatistician takes on the specific responsibility for the methodologically appropriate biostatistical activities of the clinical trial projects assigned to him 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. The biostatistical topics also include the statistical programming and the respective validation of programs.
Good knowledge of German and English required.
Responsibilities
The Senior Biostatistician takes on the specific responsibility for the methodologically appropriate biostatistical activities of the clinical trial projects assigned to him 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. The biostatistical topics also include the statistical programming and the respective validation of programs.
Good knowledge of German and English required.
Responsibilities
- To support the generation and review of the procedures, guidelines, manuals or other documents applicable to the general or project-related biostatistical activities of Biostatistics & Programming (BS). Specifically, to generate and review Statistical Analysis Plans for clinical trial projects and to generate, validate and run SAS programs as required within the statistical analysis process.
- To prepare statistical or integrated study reports as required by contracts and to take responsibility for the correct interpretation of the results within the report.
- To provide biostatistical information and assistance within the company. This includes to support the head of department in the generation of budget proposals for biostatistical activities. Upon previous authorisation of the supervisor and if required by the sponsor, to contact external parties with respect to biostatistical activities.
- To supervise and instruct the department's personnel concerning biostatistical activities of projects. If required, to prepare, conduct or assist in general and in project-related biostatistical training. Additionally, to prepare, conduct or assist in training sessions regarding biostatistical topics for sponsors or other company departments.
- To participate and support the organisation of department, group or project-related meetings. This includes to support, provide information, and participate in discussions during audits and inspections which include biostatistical activities. Additionally, to participate and represent the department in meetings and other events at sponsor's and authorities locations, research institutions and other organisations in the scope of the company, department and/or project-related activities.
- To assist the head of department in the evaluation of the group's workload, cost and manpower.
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