Biostatistician

  • Im Mediapark, 50670 Köln, Germany
  • Full-time

Company Description

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.

Job Description

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

 

Qualifications

  • 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.

Additional Information

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.

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