Clinical Trial Jobs in South Plainfield
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Search Results - Clinical Trial Jobs in South Plainfield
Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities and Requirements:
We have a long-term, 100% remote contract opportunity for a life sciences Clinical Trials Business Analyst with Study Data Tabulation Model (SDTM) experience.
Our client is currently seeking a Clinical Business...
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Katalyst Healthcares & Life Sciences-South Plainfield
This role will require someone who is creative & resourceful in researching and "grabbing R packages from the open-sources and at least 3-5 years of clinical trial development experience.
Requirements:
Organize clinical trial data (e.g., integrate EDC...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities and Requirements:
Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and Client.
Archive clinical trial data (SDTM and ADaM datasets).
Perform CDISC standard compliant checks...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Develop and maintain SAS programs to import, clean, and validate clinical trial data.
Use R for data manipulation, analysis, and visualization.
Perform statistical analyses in accordance with study protocols and analysis plans...
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Katalyst Healthcares & Life Sciences-South Plainfield
Demonstrate expertise in the SAS language, procedures, and options commonly used in clinical trial reporting - including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
Create all files, documents, and analyses necessary to support electronic submission...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities and Requirements:
8 years of experience in clinical trial data analysis using SAS. Preferably in UNIX environment Familiar with Unix command and environment.
Deep knowledge of CDISC Standards and solid ADaM programming experience...
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Katalyst Healthcares & Life Sciences-South Plainfield
investigations in preparation for new drug device or consumer application.
Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP)...
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Katalyst Healthcares & Life Sciences-South Plainfield
experience within a pharmaceutical and/or medical device company, or similar organization is required.
Ability to manager 5+ studies at a time is required.
Experience with different clinical phases.
Knowledge of clinical trial methodology and study design...
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Katalyst Healthcares & Life Sciences-South Plainfield
Clinical research, Clinical trial process, and related regulatory requirements and terminology.
Good understanding of the clinical drug development process.
Strong communication skills and coordination skills.
Current knowledge of technical...
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Katalyst Healthcares & Life Sciences-South Plainfield
Understanding of the clinical trial processes including common data standards (CDISC) and statistical outputs (SAS)....
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Katalyst Healthcares & Life Sciences-South Plainfield
Programming experience in R, SQL, JSON.
Working experience with relational databases.
Experience developing technical specifications for SDTM, ADS, or ADaM standards.
General understanding of the clinical trial process and regulations that apply (GCP, GCDMP...
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Katalyst Healthcares & Life Sciences-South Plainfield
thorough knowledge of clinical trial study design and electronic data submission requirements. Must be able to work independently on multiple concurrent projects.
Requirements:
Programming standardization activities and departmental initiatives...
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Katalyst Healthcares & Life Sciences-South Plainfield
understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG.
Strong problem-solving skills.
BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences.
7+ years of statistical programming...
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Katalyst Healthcares & Life Sciences-South Plainfield
related to clinical trials....
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Katalyst Healthcares & Life Sciences-South Plainfield
management, data quality review and database close and lock procedures, CDASH and SDTM data formats.
Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials.
Working knowledge of the MedDRA and WHO Drug dictionary coding terms...
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