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CORRECT TITLE is: Senior Principal Programmer supporting Systems and Applications. Please provide this title to the candidates. (Since there isn't a FG template for the desired title we used "Clinical Programmer " template to capture the hiring process).
Responsibilities will include, but are not limited to, the following:
Write and debug SAS programs/macros in Linux environment.
Participate, manage and perform clinical trial data migration activities from Windows to Linux. Including writing and execution of SAS macros/programs, maintaining validation documentation, activity tracking, vendor management, troubleshooting.
Provide training to study team members on data migration activities.
Provide technical support to study teams on SAS programs/macros.
Execution and support of Systems and Applications Support (SaAS) strategy and ensure alignment with department strategy.
Provide technical support to users within the department for systems and 3rd party applications, including answering/resolving user issues pertaining to the system and/or programming environment.
Support to the development, validation, maintenance and enhancement of Client global macros as well as training on the same.
Participate in the development, validation and maintenance of standard programs e.g. data review programs, TLGs, patient profiles as well as training on the same.
Participate in the implementation of standard naming convention for directories, programs, outputs and macros provide on-going training and monitor for adherence.
Monitor department computing environment for compliance to Client standards and best practices.
Participate in the creation of automated tools to assist with monitoring for adherence/compliance to Client standards and best practices.
Conduct periodic audits on the data files to ensure compliance to standard processes as well as best practices.
Identify efficiencies/optimization needed in technology and propose/share solutions /or utilities to improve the same across the department.
Proactively anticipate problems, identify root causes and work with manager to implement creative solutions.
Lead cross functional system related projects as assigned.
Provide guidance to IT and make decisions for resolving programming related tickets.
Work with IT to approve and execute server/software Change Requests (CRs) as well as on system upgrades.
Maintain user access, in collaboration with the IT departmentInteract with CROs for the development of standard programs.
BA/BS degree in life science, statistics, mathematics, computer science, or related field OR equivalent working experience required.
3+ years Pharmaceutical/CRO experience as a SAS programmer supporting clinical trials for regulatory submissions.
Demonstrated knowledge in programming environments, systems and networking as it relates to the pharmaceutical industry.
Have in-depth understanding of clinical data structure as well as relational databases
Demonstrated proficiency in using SAS
Demonstrated skills in using software tools and applications, e.g., MS office, XML, HTML, etc.
Have an understanding of regulatory requirements pertaining to technology, systems, and standards.
Ability to research new technologies and ensure alignment with regulatory agencies and industry standards
Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
Demonstrated ability to work in a team environment with clinical team members.
Excellent planning and project management skills.
Good interpersonal, communication, writing and organizational skills.
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