rimary Responsibilities
- Data Provision to Clients
- Create and execute SAS edit check programs .
- Validate edit check programs using standard validation practices and processes.
- Develop SAS programs to convert data from EDC systems to protocol-specific SAS datasets according to customer specifications.
- Assist in the creation of SAS-related project programming and validation documentation.
- Develop SAS macro and format libraries.
- Data Quality Assurance
- Review and approve User 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 of CDISC-compliant datasets .
- Generate documentation for customer-specific SAS datasets.
- Maintain the SAS environment, providing assistance with SAS installation , updates, and maintenance.
- Project Management Support
- Collaborate with the Study Quality Representative to 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 the Project Manager and other relevant personnel.
- Keep department heads informed of ongoing project issues.
- Process Improvement Efficiency
- Coordinate activities between the Clinical Programming department 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 the Training Department in developing and maintaining training materials for Clinical Programming.
Secondary Responsibilities
Team CollaborationExplore 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 LearningParticipate in applicable company-sponsored training programs to maintain and expand technical expertise.Maintaining Standards QualityRead, understand, and adhere to organizational 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 in Computer Science , Design , or a related field.Educational background in Human-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 of SAS programming experience in the pharmaceutical industry.5+ years of experience working with CDISC , SQL , and Relational Databases .3+ years of experience with database organization and 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 standardsSkills Required
cdisc, Sql, Relational Databases, Sas, Documentation