- Im Mediapark, 50670 Köln, Germany
Founded in 1997 by two Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials. Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for complex trials in Rare Diseases, Oncology and Neuroscience.
Position summary: Statisticians within the ERGOMED Biostatistics (BS) department are responsible for providing oversight of the BS part of a project, creating, updating and filing BS documentation. In close cooperation with the Project manager (PM) the Statistician is involved in communication with the sponsor. The Statistician within ERGOMED BS represents a position in first line of management under direction of the Head of Biostatistics.
Duties and responsibilities of the Statistician are:
- Provide statistical input to the clinical trial protocol and CRF
- Provide statistical consulting during all phases of a project.
- Provide oversight and coordination of all BS activities in a project.
- Coordinate the Statistical Programmers (SP) allocated to a project.
- Define, supervise and validate the creation of tables, figures and listings (TLFs) and other outputs for projects.
- Create, update and file project-related documentation (e.g. Statistical Analysis Plan (SAP)) in the BS TMF.
- Perform and document periodic QC of BS TMF files and follow up on all action items until closure
- Prepare the creation of treatment assignment randomization.
- Development of the Statistical Analysis Plan (SAP).
- Assist with writing of the statistical part of the Clinical Study Report (CSR).
- Initiate and conduct the Data Review Meetings (DRMs) for projects.
- Communication with the sponsor in close cooperation with the PM.
- Close cooperation and communication with the DM Group.
- To ensure compliance with submission requirements
- Develop, review and revision of ERGOMED SOPs within their area of expertise in order to ensure consistency with Good Clinical Practices and other applicable regulatory standards / requirements
- Contributing to ERGOMED training programs to enhance knowledge of Good Clinical Practices, Good Clinical Programing Practice, related guidance documents, ERGOMED SOPs and Working procedures.
- Deliver training and mentorship to BS and other operational staff as applicable
- Contribute to business development activities for all clinical BS business.
- Attend meetings with project team and/or client
- 5 years experience as a Statistician working within a clinical trials environment
- Excellent knowledge of SAS
- Experience with phases 2-3
- Ideally experience of complex trials such as Oncology
- Good communication skills and ability to deal with clients.
Why Should You Apply?
· You want be involved in a wide range of interesting projects and studies
· You want your achievements and hard work to be recognized
· You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.
· You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.