Company:
Katalyst Healthcares & Life Sciences
Location: Walnut Creek
Closing Date: 20/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools).
Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group.
Demonstrates in-depth knowledge of clinical development and medical data.
Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/Client.
Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations
Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies
Requirements:
Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
Intermediate knowledge of CDISC Standards
Intermediate knowledge of clinical trials
Regulatory submission experiences
Effective communication (written and verbal) skills to explain difficult information
Bachelor's degree in a Scientific Discipline
Typically requires 4 + for M.S. or above and 3+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization
Works regularly with advanced features of SAS (including interfacing ability with other software applications and operating system tools).
Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group.
Demonstrates in-depth knowledge of clinical development and medical data.
Creates all files, documents, and analyses necessary to support an electronic submission in eCTD format, including ISS/Client.
Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations
Provides technical and project management skills to create, review, and approve documentation required to support data analysis, reporting, and CDlSC data submission
Participates in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization, and integration of new tools and technologies
Requirements:
Proficiency in all SAS language, procedures, and functions commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
Intermediate knowledge of CDISC Standards
Intermediate knowledge of clinical trials
Regulatory submission experiences
Effective communication (written and verbal) skills to explain difficult information
Bachelor's degree in a Scientific Discipline
Typically requires 4 + for M.S. or above and 3+ years for B.S. years of work experience in Biotech, Pharmaceuticals or Clinical Research Organization