Specialist Statistical Study Design (m/f)

- Lead and provide oversight in the development of study protocols and data analysis plans in collaboration with physicians, and/or medical colleagues
- Responsible for working with research associates and scientists to oversee the establishment of a reporting database and the analyses of study data
- Statistical study design and analysis (mainly phase III-IIIb-IV clinical trials or observational studies
- Accountable for selecting statistical methods for data analysis
- Coordinate the statistical programming with CRO statisticians and communicates accordingly with the CRO
- Collaborate with data management in the planning and implementation of data quality assurance plans
- Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and competent in justifying methods selected
- Support medical affairs in the statistical aspects of designing, implementation and results interpretation of patient support programs
- Support for communicating study results via regulatory submissions, manuscripts or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings
- Qualification M.S., Ph.D. or equivalent experience in Statistics, Biostatistics, or equivalent of field study
- Experience in similar job
- Leadership and teamwork skills
- Self-management skills with a focus on results for timely and accurate completion of competing deliverables
- Knowledge of the SAS programming language
- Understanding in neurosciences disease states, specifically experience working in depression, schizophrenia, ADHD and/or Alzheimer
- Knowledge of regulatory compliance

Weitere Qualifikationen: Biostatistician