Informacje o stanowisku

Brief Description

The Clinical Programmer will be responsible for the provision of data review and trial management deliverables across all compounds and trials for which these are required, and for all functional groups that require those deliverables.

Essential Functions/Responsibilities

1. Program simple to complex data review listings, exception reports, QTL/KRIs, metrics reports and visualizations in a fast paced environment for clinical trial data review and management purposes.
2. Liaise with Clinical Data Management and/or cross functional staff to understand the needs of the end users of the listings, reports, and metrics.
3. Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly.
4. Create and document archives of software and deliverables.
5. Create any Work Instructions process and training documents needed related to clinical programming and the required deliverables.
6. Provide time and resource estimates for project planning as well as accurately record time spent on multiple deliverables.

Required Knowledge, Skills, and Abilities

1. Skilled in programming in a relational database setting with SQL and/or T-SQL or ETL.
2. Experience with data reporting tools in a clinical trial setting.
3. Experience in the Biotechnology, Pharmaceutical, or Life Sciences industries (Clinical Research Organization - CRO or Clinical Trial regulated environment preferred).
4. Experience with the eClinical Solutions elluminate platform a plus.
5. Experience with Qlik Sense a plus.
6. Preferred additional external data transfer experience in:
   1. Creating external data transfer specifications, ensuring external clinical trial data are compatible with the clinical database to support data integration, analysis and reporting.
   2. Experience in planning, set-up, and acquisition of external clinical data at the study level.
   3. Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.).
7. Knowledge of some additional programming languages (e.g.: SAS, PL/SQL, R, Python, Java, …) a plus.
8. Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests.
9. Familiarity with CDISC standards, including CDASH and SDTM.
10. Working knowledge of Microsoft products: Outlook, Word, Excel, Teams.
11. Excellent verbal and written communication skills.

Required/Preferred Education and Licenses

1. Bachelor’s degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields.
2. Minimum of 5 years of experience in developing software in a clinical trial environment using SQL, including at least 3 years of clinical programming experience.

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