The Role:Supports workload in one or more ALIM regional leads and will be responsible for verification of information in final printed secondary packaging component artwork...
Expert StatisticianPharma, BaselStart: ASAPContract End: December (renewal for 1 more year after)
Lead all statistical activities related to the integration: - Implementation of the data vizualisation 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 to the 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 Actelion-Janssen integration team
- 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;
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.