Senior Clinical Data Programmer-FSP
Parexel International Corporation
Organizational Relationships: Reports to Parexel FSP assigned Line Manager with day-to-day direction from the Client.Liaises with cross functional lines as appropriate. Regular interaction with Data Management, Clinical Trial Management, and Medical Management groups.
Primary Responsibilities: Programs SAS Non-System Edit Checks and SAS Data Listings. Ability to independently develop innovative and complex SAS programs to support activities including, but not limited to, data review and reporting. Develops and maintains the Non-System Edit Check Global Library to ensure consistency across programs and studies and concordance with the EDC Global Library. Trains Data Managers on how to create and review SAS program specifications, run SAS programs, review SAS logs, and generate output Works with Clinical Data Manager, Biomarker Data Specialist, Medical Monitor, and Protocol Lead (and other study team members as appropriate) to develop new or improve existing data review tools. Coordinates with Data Managers regarding timelines and deliverables to ensure all SAS programs are working as expected. Mentors less proficient Data Management SAS Programmers or other SAS users as appropriate. Independently manage SAS processes and applications while evaluating for improvements; lead working groups to develop and implement new processes and applications. May contribute to the development, review and implementation of SOPs, templates, and processes and other departmental and/or cross functional initiatives. Utilizes experience and leadership skills to provide guidance to other team members. Takes ownership of process resources available to team. Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.Adheres to EP and Client SOPs and processes.
Education and Certification: Bachelors or higher in a health-related field. SAS Certified Base Programmer for SAS 9 highly valued but not required.
Skills and Experience: 5-10 years of SAS programming experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of a portion of the years of experience. Fully conversant in SAS programming and best Clinical Data Management practices. Knowledge of and experience with clinical databases, electronic data capture systems, quality control processes and auditing procedures. Knowledge of industry standards (CDISC, SDTM, CDASH). Familiarity with GCP, ICH and FDA requirements as they apply to clinical data. Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint). Strong critical thinking skills. Excellent written and oral communication skills.
Language Skills: Proficiency in written and spoken English
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