Reference Number: 895009-W
Type of placement: Contract, 24+ Months – Strong possibility to turn permanent
Location: Switzerland, North West
Responsible to manage contract research organizations (CROs) performing data management and statistical tasks for clinical studies.
To ensure that the deliverables are provided on time, to a high level of quality and adhering to company requirements and to support clinical review of study data in SAS.
Actively manage studies performed by CROs for Data Management and Statistics (contracts, payments, timelines, quality, cost and deliverables)
Review and approve Data Management and Statistics study deliverables provided by the CRO (eCRF/database set-up, data management plan, statistical analysis plan, datasets (CDISC), tables, figures and listings) in order to ensure compliance with the study protocol and company standards
Lead the study team review of Data Management and Statistics deliverables
Provide regular feedback to company study team on study progress and activities at the Data Management and Statistics CRO
Regular review of study data with the clinical team/ safety team.
Support clinical review of data in SAS (JMP /JMP Clinical)
Lead database lock plans and activities
Coordinate development of the PK analysis between the Clinical Pharmacologist and the Statistics CRO
Perform ongoing filing of study documentation and data in document management system
Follow departmental policies, procedures, and SOPs
Qualifications and Experience:
Extensive knowledge of all aspects of data management for all phases of studies, in particular Phase III global registration trials
Good knowledge of the development of randomization lists, statistical analysis plan, allocation to analysis populations and the content of clinical study output
Experience in regulatory submissions which include datasets is preferred
Fluent written and spoken English.
Knowledge of German is also an advantage
Good knowledge of SAS programming. Experience in SAS JMP/JMP Clinical an advantage
Good knowledge of SDTM and CDASH standards.
Strong Leadership skills
Integrity and flexibility
Able to work without supervision and to take responsibility for tasks
Attention to detail
Good written and verbal communication skills
Relevant working/residency permit or Swiss/EU-Citizenship required