Provide statistical programming support to clinical trials. Produce statistical analyses, including generating analysis datasets, tables, listings, and figures for clinical trials. Support Data Management in data set creation/transfers, integrity checks, and quality audits.
- Perform assigned SAS programming required for clinical trial analysis and reporting
- Review the Statistical Analysis Plan in preparation for programming analyses
- Assist in designing/developing SAS macros and other utilities to expedite SAS programming activities
- Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
- Participate in statistical program validation and quality control activities, as assigned
- Develop SDTM mapping documents; complete programming and validation of CDISC SDTM and ADaM datasets.
- Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects
- Program data cleaning checks, as necessary, to facilitate Data Management’s data cleaning activities
- Assist in review process of study documents such as the CRF, edit specifications written by Data Management, and Statistical Analysis Plans, as needed
- 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
- Adhere to all aspects of the SDC’s quality system
- Comply with SDC’s data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
The 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.
- Sound analytical skills, with the ability to process scientific and medical data
- Proficient SAS programming skills required, with working knowledge in SAS/Base, SAS/Stat and SAS Macros. Basic understanding of SAS/Graph
- Experienced in manipulating and analyzing 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
Education or Equivalent Experience:
Bachelor’s degree in computer science, statistics or other related, scientific field and three years of relevant professional experience; or an equivalent combination of relevant education and/or experience.