Vereinigte Staaten, Indiana, Indianapolis
The Senior Data Scientist is a leading member of the Data Management, Biostatistics and Data Science department. This position is a key contributor in the support of R&D and Clinical Operations activities through programming and project management. Collaboration and coordination of activities with other employees is prioritized. Networking and negotiation is required with senior internal and external personnel as well as some key contacts outside area of expertise including R&D, IT, Software Engineering, Quality, Regulatory and Clinical Operations.
A seasoned professional with wide-ranging experience to manage diverse and often times complex issues, where analysis may require in-depth evaluation of many factors. Exercises judgment in evaluating methods and may determine criteria for obtaining solutions. May coordinate the activities of other employees. Networks with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
What you do
- Statistical Programming activities are planned and study conduct is continuously supported
- Data Management support for clinical operations and study analytics is provided
- Clinical programming and eCRF configuration is performed
- IT project support/Data Engineering for DM/Biostatistics group and SOP related updates are supported
Who you are
- Bachelor or Masters in Statistics or other science/engineering degree
- Clinical trial management or medical documentation or bioinformatics or informatics or biostatistics MSc, strong background in natural sciences
- > 5 years experiences with R or SAS statistical programming, databases (clinical studies, SQL), clinical programming, process and project documentation, international team work and communication
- High level: clinical databases, GxP, FDA regulations, DCC, English language, clinical information management in R&D
- Medium level: statistical programming and knowledge (including R, SAS, SQL and Tableau/SPSS) and clinical programming, data analytics, project management; fundamentals: medical terminology
- Statistics / Data Science / Data analytics knowledge
- GCP – Good Clinical Practice / Understanding of clinical trials.
- FDA and other health regulatory bodies
- Master's degree in statistics