Hobson Prior are currently working with a manufacturer of defibrillators and heart stimulators for a Statistical Programmer to join them on a contract basis in Paris.
You will be accountable for statistical programming activities in support of clinical trials, including oversight of vendors and contract programmers to insure quality deliverables, and to validate results.
Job Responsibilities :
Design, develop, document and maintain computer programs to derive, store, analyze and report clinical data.
Represent as the lead statistical programmer to support all clinical programs and work collaboratively within Clinical Project Manager to meet deliverables and timelines for statistical programming and reporting.
Accountable for insuring quality and integrity of statistical programming to meet current regulatory requirements and industry standards.
Works closely with Data Management and Biostatistics, to ensure final databases, analyses, and reports are accurate.
Collaborate with Data Managers to provide input on CRF design, CRF annotation, edit checks, and data review plans.
Deliver inputs into SAP, analysis presentation and data presentation.
Contribute to the development of departmental programming SOPs and implementation of Good Programming Practices.
Work according to ICH-GCP, other internal guidelines (e.g ISO), working group recommendations (e.g CDISC) as well as internal quality system.
Ensure proper documentation according to internal guidance documents.
Develop and maintain metrics for the management of clinical trial conduct.
Perform quality control checks of SAS code and output produced by other Statistical Programmers.
Key Skills :
Excellent communication is required.
Fluent in English.
University Degree in computer science.
Extensive experience as a Statistical Programmer in the Pharmaceutical / Medical Industry.
Have advanced knowledge / experience programming in SAS : SAS / BASE, SAS / MACRO, SAS / ODS, SAS / SQL.
Working knowledge of good programming practices, basic statistics, GCP, ICH guidelines.
Good knowledge and understanding of CDISC SDTM and ADaM standards.
Apply now :
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