Ensure statistical analysis and SAS programming tasks required to support conduct and reporting of clinical trials under supervision and guidance of project statistician.
Key activities and responsibilities
- Performs statistical analyses and SAS programming according to Statistical Analysis Plan (SAP) or other relevant information.
- Ensures generation of Tables, Figures and Listings as per Standard Operation Procedures.
- Contributes to review of SAP and preparation of TFLs shells in order to check that it includes all details needed for programming.
- Interacts with project team in order to ensure task defined above.
Competences, skills and qualification
- Master degree in (Bio-)Statistics/ Mathematics (graduated or in last years of studies)
- Ability to analyze clinical data. Experience in analysis of biological data/clinical trials data is an advantage.
- Experience with SAS programming (data handling, analysis, reporting)
- Skills to provide suggestion for solution of unexpected situations via data handling or analysis.
- Ability to work in environment of clinical trials including a must to follow guidelines, necessity to make a proper documentation related to statistical analysis, validation and reporting of the outputs, and to keep compliance with timelines. Knowledge on ICH and FDA guidelines is an advantage.
- Skills to work independently and cooperate with Clinical Data Management (CDM) and clinical team.
- Fluent communication in English.
- Opportunity to get experience in design and analysis of clinical trials data and related processes.
- Directly participate in studies of novel drugs/therapies for cancer in biotechnology company.
- Work in international team.