Sr Clinical Programmer, FSP
Remote from anywhere in the U.S. or Canada
Performing SAS programming to provide complex listings/reports to support Data Mgmt. function to clean data for Oncology trials
Develop programs to provide patient profiles, missing pages report, coding reports and ad-hoc reports for data review to support the clinical teams
Designing and developing SAS macros, standard programs, applications and other utilities to expedite SAS programming activities and usage by Clinical Data Management and other areas of Clinical for data review
Developing and maintaining the programs with proper documentation and testing using departmental standards
Ensuring all programming activities and processes performed are conducted according to standard operating procedures and good programming practices.
Provide technical guidance to other SAS programmers as necessary
Ensures timelines and deliverables are tracked for self and others in the team
Responsible for the loading of external data into the database management system using SAS and/or SQL code as necessary. To be able to receive, track and load the external data into the database system and answer client questions concerning the processing of this data. To interact with suppliers of external data in negotiating format and method of transfer from said supplier to Company.
Have to ability to perform problem solving and troubleshooting for system procedures and processes that may arise in course of a clinical trial as related to the clinical database.
Have the technical knowledge and provide guidance on providing interfaces or data exchanges between the Clinical database and other database, programming or reporting systems. Be able to export data or allow views of data from the Clinical database to other computer systems in a secure and verifiable method. When necessary provide support for tools which require access to the clinical database
Self starter and able to work independently with minimal supervision
• University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology).
• Broad knowledge of drug development process.
• Basic knowledge of budgets and relationship to productivity targets.
• Working knowledge of CDISC.
• Working knowledge of System Life Cycle in relationship to the implementation new applications.
• Fluent in English, both written and verbal.
• Minimum six years of relevant work experience to include database programming activities using SAS.
• Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions.
• Demonstrated skill in leading teams, by example and mentoring staff.
• Excellent oral and written communication and presentation skills.
• Knowledge of clinical trial process and data management, CRF/eCRF Design, CDISC.
• Experience working with data from at least one EDC system like Medidata Rave or Oracle Inform
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
• Demonstrated ability to work in a team environment.
• Demonstrated ability to handle multiple competing priorities.
• Proven managerial and interpersonal skills.
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