ProClinical are recruiting for a Senior Statistical Programmer and a Principal Statistical Programmer to work at a leading multinational contract research organisation. The organisation is one of the world's forefront innovators in biopharmaceutical services, providing high quality Phase I-IV clinical research, regulatory, consulting, and market access services. The positions will be with the company's German office; however, they can be set in any EU location in a home-based capacity. These vacancies offer an exciting opportunity to work with a prestigious CRO that pioneers drug development.
Job Responsibilities:
The Senior Statistical Programmer's Responsibilities include:
- Providing technical expertise for the conduct of clinical trials,
- Acting as an internal subject matter expert in specific areas, providing technical support and expert advice and working independently to support various programming activities related to the analysis and reporting of clinical study data.
- Filling the Statistical Programming Coordinator role on projects, liaising with sponsors, Data Operations Leads, and other functional areas as required.
- Importing/exporting programming specification development, test data creations, and test data entry.
- Importing/exporting programming functional testing.
- Mapping specifications to support relevant data standards.
The Principal Statistical Programmer's Responsibilities include:
- Acting as a subject matter expert, providing technical support and expert advice to internal and external sponsors.
- Filling the Statistical Programmer Coordinator role on projects, liaising with sponsors, Data Operations Leads, and other functional areas as required.
- Monitoring quality, timelines, resource allocation, and productivity in relation to budgets.
- Importing/exporting programming specification development.
- Testing data entry.
- Importing/exporting functional testing.
- Mapping specifications to support relevant data standards.
Skills and Requirements:
- Proficiency in SAS.
- Knowledge of the programming and reporting process.
- Knowledge of WSOPs/Guidelines/System Life Cycle Methodologies, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
- Demonstrable application of CRS concepts to achieve best practice and promote continuous improvement.
- Demonstrable ability to learn new systems and function in an evolving technical environment.
- Business/Operational skills that include customer focus, commitment to quality management, and problem solving.
- Good business awareness/business development skills, including financial awareness.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Theodora Savlovschi-Wicks at +44 203 752 0314 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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