Responsible to performs or oversees performace of the statistical tasks of individual clinical trials from design, through statistical analysis and programming, to reporting.
Acts as the project statistician on multiple clinical trials including cooperation with other clinical trial team members and management within statisticians/SAS programmers team allocated to individual clinical trials.
Contributes to set up, maintain and improve processess within Biostatistics Department.
Key activities and responsibilities
- Contributes to designing, set up and writing of relevant study documents (e.g. study protocol, IDMC/DSMB charter) including all the relevant internal and external communication.
- Writes Statistical Analysis Plan (SAP) and ensures shells preparation with proper level of validation.
- Writes or contributes to other plans related to statistical activities.
- Performs statistical analyses and SAS programming according to Statistical Analysis Plan (SAP) or other relevant information.
- Ensures generation of Tables, Figures and Listings (including TFLs for Clinical Study Report, Data Safety Update Report, IDMC/DSMB).
- Ensures review of Clinical Study Report and other outputs presenting interpretation of study results.
- Manages and supervises statistical activities within individual clinical trials taken into account projects’ needs, agreed timelines and requests of Standard Operation Procedures and relevant guidelines.
- Manages budget(s) allocated to the statistical activities in cooperation with project management.
- Serves as internal primary contact in statistical aspects of the project.
- Ensures reporting on project level, quality of deliverables, compliance with agreed timelines.
- Supervises and guides Junior Statisticians/SAS programmers.
- Contributes to selection of vendors for statistical services, ensures supervision and interaction with vendors/contractors providing statistical support in the project.
Competences, skills and qualification
- Experience as biostatistician of clinical trials (experience in clinical trials in oncology or in early phases of clinical drug development).
- Master degree in (Bio-)Statistics/ Mathematics (graduated or in last years of studies)
- SAS programming skills (data handling, analysis, reporting).
- Skills to provide suggestion for solution of unexpected situations via data handling or analysis.
- Pro-actively thinking person.
- Knowledge of 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.
- Skills to work independently and cooperate with Clinical Data Management (CDM) and pre-clinical/clinical team.
- Fluent communication in English.
- Directly participate in studies of novel drugs/therapies for cancer in biotechnology company.
- Work in international team.