Founded in 1997 by a Medical Doctor, 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.
The preferred position is Ergomed's office for Data Management and Biostatistics in Cologne/Germany or can be home based or from any of our global offices.
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
- MS and/or PhD degree in Statistics or Biostatistics or related field
- Understanding of statistical concepts and techniques
- Expertise in SAS
- Knowledge of CDISC standards, including SDTM and ADaM datasets
- Excellent communication skills
- Fluent in English
- Basic familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
- 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