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
Principal Statistical Programmer
Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group. ...
Principal Statistical Programmer
Performs quality control checks of SAS code and output produced by other Statistical Programmers to ensure accuracy and consistency within group. ...
Programmer Analyst (COBOL)
Be part of a team that unleashes the power of leading-edge technologies to help improve the health and well-being of those most vulnerable in our country and communities.Working at Gainwell carries its rewards.You’ll have an incredible opportunity to grow your career in a company that values work fl...
Business Analyst & Building Coordinator (4628U) - Dept of Astronomy
Applies financial and business services concepts to support department members, resolve issues, and prepare business procedures and policy recommendations as the primary point of contact for all financial and business services duties. Financial and business services duties:. Responsibilities include...
Sr. Programmer Analyst - 130695
Programmer Analyst applies skills as a seasoned, experienced software professional with a full understanding of industry practices, community standards and relevant policies and procedures to medium-sized projects or portions of large projects with moderate scope and complexity. Programmer Analyst a...
Software Developer - Full Stack
Working within Bio-Rad's Clinical Diagnostics Group R&D organization as a Software Developer - Full Stack, your day will consist of a couple of meetings including a daily standup where you will report your progress towards tangible work outcomes, and request help from others as needed. Work with int...
IT Business Analyst, Senior
The Enterprise Protection Business Intelligence & Operations (EPBIO) team is part of IT’s Enterprise Protection Data & Analytics (EPD&A) organization that manages the business operations for Cyber Security, Corporate Security, Enterprise Data Management and Data Analytics & Insight departments. Busi...
Senior Software Engineer
Job Title: Senior Software Engineer. Software Developer: We are looking for a highly skilled Software Developer to join our dynamic Scrum team working on the next generation of a leading medical diagnostic device. Adhere to coding standards, software design principles, and best practices to ensure s...
Entry Level Software Developer Role
Year Up United is a one-year or less, intensive job training program that provides young adults with in-classroom skill development, access to internships and/or job placement services, and personalized coaching and mentorship.Year Up United participants also receive an educational stipend.The progr...
Senior Statistical Programmer
A biopharmaceutical company in the Bay area needs a Senior level Statistical Programmer to support the team’s leading program. This individual will need to be a strong, senior-level programmer who can work well both independently and part of a team. ...