Principal Statistical Programmer - Real World EvidenceOffice or home based EuropeThe role
* Responsible for providing support to Manager
* Responsible for leading programmes of work or individual projects of all types.
* Responsible for performing programming activities according to business SOPs and sponsor requirements.
* Responsible for all aspects of quality and compliance of assigned projects.
* Drive efficiency through standards, automation, process improvement and technological advances.
* Drive efficiency through resource, time line and project management.
* Responsible for generation of documentation and SAS code required and generation of report tables, listings, figures and datasets.*
Act as study lead for a project to coordinate all study activities.
* Ensure projects are conducted in accordance with internal SOPs, client requirements, and Good Clinical Practices (GCP).
* Review and provide input to project documentation as appropriate including reviewing statistical analysis plans and CRF's.
* Understand project scope and budget.
* Carry out quality control checks to ensure compliance with Company and Sponsor requirements.
* Ensure accuracy of all results and ensure appropriate documentation.
* Prepare graphs, tables and listings for inclusion in clinical study reports.
* Write/follow appropriate SOP's and WPS for programming activities.
* Lead by example to ensure efficient programming practice is maintained.
* Provide support to the Manager, Statistical Programming.
* Perform senior review of complete programming deliverables.
* Ensure compliance with all training requirements.
* Provide data transfers to company or sponsor standards.
* Participation in client audits where appropriate.
* Attend and present at external meetings as appropriate.
* Liaise with Data Management, QA, PK, Medical Writing, Stats and PM.
* Ensure oversight of packages of work for a sponsor including; lessons learnt between studies, gaining efficiencies through sponsor level automation and standards, leading the technical aspects of sponsor communication/governance, functioning as a single point of contact for project information, addressing any sponsor level quality issues including CAPAs.
* Provide input to the appraisal process for staff support projects or mentorees.Requirements
- Relevant degree
- Significant experience as a Statistical Programmer in Clinical Research