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Form of workJob Description
A diversified global healthcare leader, focused on developing products that meet the health needs of people. We have extensive lines of prescription medicines and vaccines, as well as consumer health products.
Experience in the Biotech/Pharmaceutical industry needed.
Description
As part of the Clinical Data Management team, the candidate will support requirements analysis, programming and system development for analyses of clinical data, primarily raw electronic data capture system extracts and specialty lab data. Candidate will prepare, execute, report and document data cleaning support deliverables for assigned projects. Candidate will perform data validation and develop programs for Sample Management and Data Management using Python/Spotfire, SAS and/or R/RShiny. Candidate will work with the clinical trial team to identify and execute project requirements according to the Data Review Plan (DRP) and will support programming deliverables through project milestones from study start-up to database lock. Additionally, the Candidate will collaborate with Statistical Programming to develop SAS macros for department standards and analytics dashboards for data review(e.g. Spotfire), and to ensure that data cleaning programs are consistent with SAS summary tabulation programs (e.g. treatment emergent adverse event counts match).
RESPONSIBILITIES
• Configure and execute tools and/or programs to generate Patient Profiles for Data Validation, Data Review & Medical Review.
• Develop standard and ad hoc listings/summary tables/figures for data Validation/sample management/data review/medical review/AE dedicated review/SAE reconciliation in various formats and distribute the outputs to the cross-functional team.
• Per the DRP, develop re-usable reports, data sets, and analytic integrations, working with customers, internal teams, and data scientists where required.
• Perform/support statistical analyses, create derived datasets and SAS programming to create complex macros for data processing.
• Experience in reviewing CRFs, SAPs, output mock shells and Protocols from a programming perspective.
• Ensures that Clinical Programming activities are conducted in accordance with GCP, internal SOPs and all regulatory requirements.
• Check that CDISC Controlled Terminology is correctly applied.
• Check Laboratory Unit conversions.
• Apply mapping for external data.
• Work with internal technology teams to optimize analytics platforms and Big Data environments to support reporting and analytics solutions for the team.
EDUCATION / REQUIREMENTS
Position Qualifications and Experience Requirements
• Bachelor’s Degree in Computer Science, Informatics, Information Systems, or related field with 6+ years’ relevant experience
• Advanced SAS, SQL and Data Blending Skills preferred
• Good knowledge of CDISC standards including CDASH, SDTM, ADAM, ERT-DDS etc.
• Advanced knowledge of SAS Macros
Preferred Qualifications
• Extensive knowledge on technologies and trends related to Research and Development including big data, advanced analytics, and Internet of Things
• Prior experience with R analytics, Spotfire, Tableau, Power BI or any combination. Preference for expertise in more than one platform
Competencies
• Experience with other programming/query languages (e.g., Python, JavaScript)
• Clinical data management experience
• CRO management experience
• Clinical trial development knowledge including phase I
• Experience working in a global team/environment
