Dana Bräuer

As a member of the global integrated analysis team I am responsible to generate CDISC SDTM compliant datasets and CDISC ADaM compliant analysis datasets including data from several studies for integrated summary of safety (ISS), integrated summary of efficacy (ISE) and other integrated analyses.

As a member of the global integrated analysis team I am responsible to generate CDISC ADaM compliant analysis datasets including data from several studies for integrated summary of safety (ISS), integrated summary of efficacy (ISE) and other integrated analyses.

- Planned resources. - Established and maintained SOPs - Created proposals - Mentored team members - Performed tasks of a Biostatistician and Senior Biostatistician

- Provided project guidance - Developed and validated multi-use SAS Macro according to GAMP - Performed tasks of a Biostatistician

- Planned Statistical Analysis (i.e. sample size calculation, SAP) in accordance to ICH topics E3, E6 and E9. - Programmed statistical analyses using SAS. - Planned and created analysis datasets applying CDISC ADaM standard. - Described ADaM datasets using CDISC define.xml 2.0 standard. - Derived non-compartmental PK parameters

Participation in data analysis using SAS and data entry.

As an intern I developed a Matlab-routine for the calculation of internal waves’ decomposition based on temperature profiles.

Statistical methods, statistical modelling and their computer-assisted interdisciplinarity application. Personal focus on biometrics. Diplomas theses: Developement of VBA.NET modules for homogeneity tests incl. p-value estimation by simulation and a user interface.