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.

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 
• 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.