Birgit Weinkauf

Program statistician, CNS compound International teams (Asia, US, EU) Submissions Japan, China Strategic input to clinical development plan, submission plan, CCDS, IB, life cycle of a compound Review CTDs/consultation material Oversee program activities Guide trial statisticians within the clinical program Develope, maintain and ensure standardization within a clinical program Develope simplification tools Initiate process improvement within/across functions Strategic partnering initiative

Responsible trial statistician in CNS projects Supported EMA and FDA submissions of CNS compounds Clinical Program statistician for a CNS compound (co-development) EMA submission including agency meeting for a CNS compound in an orphan disease

Responsible statistician in clinical studies phase II – IV primarily in oncology and transplantation, several studies in dementia and chronic pain

Reviewed public health project foreseen to be founded by BMBF Trained students and employees in statistical methodology Supported in analyzing data and interpreting results Member of the task force on statistical methodology

Thesis: Statistical aspects in analyzing clinical studies in breast cancer