Senior Statistical Programmer
- Kyiv, Ukraine, 02000
- Employees can work remotely
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.
Statistical Programmers (SP) within the ERGOMED Biostatistics (BS) department are responsible for programming tables, listings and figures or other types of output, supporting the Statisticians and Data Managers of a project and creating, updating and filing BS documentation. The Statistical Programmer within ERGOMED BS represents a position under direction of the Head of Biostatistics supervised by the Statistician.
Duties and responsibilities of the Statistical Programmer are:
- Follow existing SAS infrastructure and processes to develop required deliverables.
- Develop SAS coding and templates for preparing, processing and analysing clinical data following internal discussion and agreement with senior management team.
- Work together with Data Management colleagues to develop the SAS Database for assigned studies.
- Assist with Data Management Plan (DMP)/Statistical Analysis Plan (SAP) writing.
- Review eCRF and third-party data specifications in accordance to CDISC requirements and study protocol and SAP.
- Identify and program offline SAS checks per the data validation/management plan.
- Assist in preparation and implementation of treatment assignment randomization.
- Assist Database Developer/Data Manager with the import of external data into the clinical database.
- Import data from the clinical database and other data sources for purposes of statistical analysis.
- Export data from the clinical database and SAS analysis data sets, e.g. in CDISC SDTM and/or ADAM format.
- Provide QC oversight of any SDTM/ADAM datasets and/or TFLs prepared by external vendor where assigned.
- Prepare SDTM and ADAM dataset specifications in accordance to CDISC guidelines.
- Program tables, listings and figures in SAS and implement analyses as specified in the protocol or the SAP whilst working in close collaboration with project statistician
- Export data from the analysis data sets, e.g. in CDISC ADaM format
- Perform quality control on SAS outputs as required.
- Develop SAS reporting/data transfers for ongoing trials to identify study conduct or data quality issues.
- Have good regular communications with internal team to successfully prepare deliverables for sponsor clients.
- Record all billable and non-billable time in the timesheet management system and monitor this against planned study budget.
- File project-related BS documentation (e.g. Statistical Analysis Plan (SAP), Program Validation Documentation etc.) in the BS TMF as per Ergomed guidelines.
- Assist with QA and Audit requirements and ensure all activities are compliant with Ergomed and agreed quality system standards, relevant GCP standards.
- Assist with Clinical Study Report (CSR) compilation.
- Attend meetings with project team and/or client when needed.
- Support team with training as required.
- Support BS/DM personnel recruitment as required.
Previous experience as a statistical programmer preferably within a pharmaceutical, clinical or health care setting.
We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to develop a career in clinical drug development.