Location
: Gräfelfing, Bavaria, Germany
Contract
: 1 year with possible extension
Kelly FSP, on behalf of our client, is seeking a skilled Biostatistician/Clinical Data Analyst to support and drive clinical research initiatives.
Tasks:
* Establish a central database for clinical trial data and define and program relevant analyses and dashboards.
* Develop the statistical components of clinical trial protocols.
* Coordinate the selection of and collaboration with service providers (CROs) for biostatistics and programming, ensuring high quality and timely deliverables.
* In partnership with CROs, define the strategy for statistical analysis of clinical trials and review statistical analysis plans (SAPs).
* Oversee data preparation for integration into the central database.
* Perform statistical analyses independently, review CRO-provided analyses, interpret findings, and present results to the project team.
* Contribute to the preparation of clinical study reports (CSRs) and market approval dossiers.
Profile:
* Completed MS/MA degree or doctorate in biostatistics or a related field, with at least 2 years of relevant professional experience.
* Prior experience in clinical research and working with eCRF, eCOA, ePRO, and clinical databases (e.g., Medidata).
* Proficiency in programming data analyses in R or other programming languages such as Python or SAS.
* Experience in coordinating service providers in data management and biostatistics.
* Detail-oriented with strong analytical and organizational skills, and the ability to work independently.
* Skilled at presenting complex information clearly to senior stakeholders.
* Fluent German and English language skills are required.
If you are passionate about advancing clinical research through statistical expertise and innovation, we look forward to your application