The development of programming scripts for data retrieval, transformation and representation as well as their validation will be the main focus of this role.
The 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, the 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 (eg, IxRS systems, eDiary, central laboratory, central ECG) and their related documentation.

Key Responsibilities:

·Utilize existing SAS macros for data centralization.

·Update SAS macros based on new requirements or specific file transfer needs.

·Use SAS code to interpret study documentation and classify legacy data.

·Automate processes that are currently done manually, such as filling in trackers.

· 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.

·Planning and reporting of clinical trials via exploratory analyses of available data

Experience

At least 4+ years of experience in either clinical data management and/or statistical programming/SAS Programming, within the CRO/pharmaceutical environment.
Understanding of data management and/or statistical programming processes and standards.
Experience in statistical programming using the SAS software or reports programming.
Strong SAS Macro Programming skill
Knowledge in CDISC standards (CDASH, SDTM, ADaM)
Strong understanding of different study deliverables and their information types.
Knowledge of the differences between legacy tabulation data and SDTM standardized tabulations.
Ability to work effectively in a team setting, and to meet set goals by managing own timelines

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