Senior Clinical Programmer

Senior Clinical Programmer

Location: home-based in Eastern EU (Poland, Hungary, Serbia)

Why IQVIA

Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading CRO while operating within a sponsor environment and utilizing sponsor systems. Being part of DSSS means being part of a passionate team dedicated to advancing medicine and reshaping healthcare. Your role will be both challenging and rewarding, making a real impact.

Experience the best of both worlds and become a core part of our dynamic team today!

Additional Benefits:

• Home-based remote work opportunities
• Great work/life balance
• Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors 
• Cohesive team environment fostering a collaborative approach to study work
• Variety of therapeutic areas, indications and, study phases
• Job stability; long-term engagements and development opportunities
• Career advancement opportunities

Summary:

This role leads the development and maintenance of data quality standards and performs the necessary programming and validation steps to ensure that regular and on-demand data quality control can be performed in clinical studies. The role will support the clinical study team with the identification, specification, and implementation of relevant listings and reports to ensure that adequate data quality will be achieved for clinical trials. Furthermore, this role will lead the development and implementation of programs to ensure the quality of data deliveries as they are provided by contract research organizations. These are mainly but not limited to eCRF raw data, datasets in submission ready standard format (SDTM, ADaM), and data from external sources as they have been collected in clinical trials (e.g., IxRS systems, eDiary, central laboratory, central ECG) and their related documentation.

Main Responsibilities and Accountabilities:

• Collaborates with the clinical study team in developing ongoing data quality standards and clinical data acceptance rules for clinical data in the eCRF and related external data sources collecting data from clinical studies.
• Leads the implementation and maintenance of internal data quality control programs, acceptance criteria for data from external sources and performs the related programming.
• Leads the set-up and maintenance of a suite of reports that function as a sample report library for study teams to choose from in order to help them efficiently lead their projects.
• Leads the implementation and organization of automated regular reports on study platforms and oversees correct processing of automated reports.
• Collaborates with peers, data management and statistics to ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e. SDTM, ADaM, define.xml). Supports the review of related deliverables.
• Leads the development of Data Visualization tools providing information about data quality, study metrics, etc.
• Performs data storage in a format that allows pooled analyses and exploration of legacy data and ensures a smooth data retrieval processes.
• Additional tasks:
• Supports CR&D staff in any data standards related questions.
• Collaborates in the development of strategies for the integration of non eCRF data in the eCRF database, provides technical support to internal team members as well as to external vendors as requested by study team.
• Leads data exchange with other CR&D groups like e.g. Statistics, Pharmacometrics, Medical Writing & Disclosure etc.
• Perform statistical analyses and SAS programming to:
• support responses to regulatory agencies
• support clinical safety monitoring of safety signals
• generate integrated summary of safety and efficacy
• support publications and presentations
• support planning and reporting of clinical trials via exploratory analyses of available data
• replicate CRO and client statistical analyses for QC

Education and Qualifications:

• Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience.
• At least 5 years of experience in either clinical data management and/or statistical programming, within the CRO/pharmaceutical environment.
• Understanding of data management and/or statistical programming processes and standards.
• Knowledge in statistical programming using the SAS software or reports programming in reporting tools such as Business Objects or J-Review.
• Knowledge in CDISC standards (CDASH, SDTM, ADaM)
• Ability to work effectively in a team setting, and to meet set goals by managing own timelines
• Ability to work in cross-functional, multicultural, and international clinical trial teams.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com