We have an exciting opportunity for an Expert Statistician to support Integration Activities in the Basel Area.
This is a 12 months’ contract (likely to be prolonged beyond a year)
RESPONSIBILITIES AND TASKS
Lead statistical activities related to the integration of two organisations, including the following:
- Implementation of the data visualization system to improve efficiency of the medical review and central clinical monitoring
- Align the statistical analysis plan and programming specification templates
- Develop a process for managing the data sharing initiatives (internal and external)
- Contribute to the implementation of and migration of clinical studies to a new statistical computing environment (SCE)
- Lead the activities related to migration of studies to a new data warehouse
- Contribute to the data planning meeting implementation workstream and other cross-functional activities as needed
- Collaborate with other clinical development functions to ensure alignment between the different integration workstreams
- Prepare the training and communication materials for the biostatistics department
- Represent the statistical department in the integration team
REQUIRED QUALIFICATIONS AND EXPERIENCE
- At least 8 years of experience as a clinical statistician
- BSc in Applied Statistics, or MSc in Statistics or related discipline, or PhD in Statistics
- Excellent team player
- Excellent communication skills
- Good project management skills
- Demonstrated expertise in developing, maintaining or updating processes
- Excellent knowledge of Good Clinical Practice (GCP), laws and ICH
- Has a good understanding of the software and systems used in Biostatistics in clinical development
- Good knowledge of data collection principles and software (CRF, eDC)
- Good knowledge of CDISC and common data model principles
- Excellent knowledge in statistical application to clinical trials in at least 2 different disease areas
- Sound experience in different phases of clinical drug development
- Knowledge of international clinical research regulations and requirements;
- Capability to manage outsourcing activities
- Capability to work toward deadlines, plan and deliver accordingly
- Problem-solving skills
- High level of accuracy and attention to detail
- Work efficiently in a matrix-managed environment
- Strong spoken and written English
Are you interested in this challenging opportunity?
Then we look forward to your application via our online-portal or directly to Madeleine Wirz (email@example.com)*
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