Job Summary
Works as part of a project team to create and execute SAS programs in support of Clinical Data Management. This person will be creating and executing SAS edit check programs, validating edit check programs using standard validation practices and processes, creating, validating and executing SAS programs and macros, utilizing SAS programming skills to provide ad-hoc reports (external and internal), assist in developing programming specifications, assist in creating program specific validation plans, review data transfer specifications and create data reconciliation programs, and identifying and implementing solutions for complex reporting needs.
Primary Responsibilities
Perform assigned clinical SAS programming required for clinical trial data management, analysis and reporting. Work under the direction of lead clinical data managers and clinical programmers in completing clinical trial programming tasks to ensure accurate for project needs Review the Data Validation Manual, Study Report Specification, and Data Transfer Agreement (project level specifications)in preparation for programming Working directly with clinical data manager, and where needed with clinical project manager and other team members to ensure specifications are clear and accurate. Apply good programming techniques to minimize manual review efforts Assist in designing/developing SAS macros and other utilities to expedite SAS programming activities Generate edit checks, listings, reports and graphs to ensure efficiency and accurate for data management or client review needs Perform EDC to SAS exports accounting for completeness (record counts) and all data present (variable level checks) Participate in clinical SAS programming validation and quality control activities, as assigned Interact with other departments, such as Clinical Operations, Project Management, Biostatistics and Statistical Programming, IRT and Data Management to ensure a high level of client satisfaction through successful execution of projects Timely completion of assigned tasks within budgeted hours Utilize the Infrastructure for project files of SAS datasets and SAS code Ensure all programming activities and processes performed are conducted according to SDC's standard procedures and/or sponsor requirements Utilizing SDTM guidelines to create transfer datasets Participating in project meetings (internal and external) Participating in the development of data editing conventions, specification documents and Clinical Data Management (CDM) processes Contributing to, designing and maintaining a library of reusable code Adhere to all aspects of the SDC's quality system Comply with SDC's data integrity amp; business ethics requirements Perform other related duties incidental to the work described herein Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirementsThe above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Skills
Sound analytical skills, with the ability to process scientific and medical data Proficient SAS programming skills required, with expert knowledge in SAS/Base, working knowledge in SAS Macros. Basic understanding of SAS/Graph Experienced In manipulating and transposing SAS data Ability to identify data issues, present problems, and implement solutions Problem-solving skills Able to work with minimal supervision Good organizational and time management skills Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) Strong interpersonal communication and presentation skills BASE SAS and Advance SAS Certification or equivalent experience is preferred Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitudeEducation or Equivalent ExperienceBachelor's degree in computer science, statistics or other related, scientific field and two+ of relevant professional experience; or an equivalent combination of relevant education and/or experience.