rimary Responsibilities
- Data Provision to Clients
- Create and executeSAS edit check programs.
- Validate edit check programs using standard validation practices and processes.
- DevelopSAS programsto convert data from EDC systems to protocol-specific SAS datasets according to customer specifications.
- Assist in the creation ofSAS-related project programmingand validation documentation.
- Develop SAS macro and format libraries.
- Data Quality Assurance
- Review and approveUser Requirement Specifications (URS),Clinical Data Management (CDM)conventions, and related documents.
- Develop and implement new CDM systems or enhancements to current systems.
- Ensure the creation ofCDISC-compliant datasets.
- Generate documentation for customer-specific SAS datasets.
- Maintain the SAS environment, providing assistance withSAS installation, updates, and maintenance.
- Project Management Support
- Collaborate with theStudy Quality Representativeto test protocol-specific SAS conversion programs.
- Assess and assign target dates for project timelines, adhering to these dates in conjunction with your manager.
- Communicate any changes in project timelines to theProject Managerand other relevant personnel.
- Keep department heads informed of ongoing project issues.
- Process Improvement Efficiency
- Coordinate activities between theClinical Programmingdepartment and other related departments (Operations Programming, Study QA, PM, and DM) for improved efficiency.
- Evaluate current procedures and work instructions, recommending improvements to achieve departmental objectives.
- Assist theTraining Departmentin developing and maintaining training materials for Clinical Programming.
Secondary Responsibilities
- Team Collaboration
- Explore new opportunities to add value to departmental processes and the organization as a whole.
- Support team members in achieving goals and contribute to team success.
- Perform additional duties as assigned and deemed necessary.
- Technical Knowledge Continuous Learning
- Participate in applicable company-sponsored training programs to maintain and expand technical expertise.
- Maintaining Standards Quality
- Read, understand, and adhere toorganizational Standard Operating Procedures (SOPs).
- Assist in establishing and enforcing departmental standards.
- Provide recommendations on operational procedures and actively engage in process improvement initiatives.
Qualifications
Education
- Bachelor s degree inComputer Science,Design, or a related field.
- Educational background inHuman-Computer Interaction,Usability,User-Centered Design,User Experience,Information Design,Applied Psychology,Cognitive Science,Human Factors,Informatics, or other design/applied science fields is a plus.
Experience
- 8+ years ofSAS programming experiencein the pharmaceutical industry.
- 5+ years of experience working withCDISC,SQL, andRelational Databases.
- 3+ years of experience withdatabase organizationand the ability to extract data to generate listings and reports.
Additional Skills
- Ability to work both independently and as part of a group.
- Strong attention to detail and a meticulous approach to work.
- Excellent communication skills, both verbal and written.
- Strong documentation and organizational skills.
- Professional and positive attitude with a focus on maintaining high standards
