Job Summary
Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating SDTM datasets, analysis datasets, tables, listings, and figures for clinical trials.
Primary Responsibilities
- Perform assigned statistical programming required for clinical trial analysis and reporting
- Work under the direction of senior statistical programmers in completing clinical trial programming tasks
- Review the Statistical Analysis Plan in preparation for programming analyses
- Apply appropriate statistical methods for data analysis
- 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
- Assist in development of SDTM aCRF and specifications; complete programming and validation of CDISC SDTM and ADaM datasets
- Develop define.xml and create table of contents of programs for regulatory submissions
- 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
- 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
- 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 requirements
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.
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/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
- BASE SAS and Advance SAS Certification or equivalent experience is preferred
Education or Equivalent Experience
- Bachelor's degree in computer science, statistics or other related, scientific field and two to four years of relevant professional experience; or an equivalent combination of relevant education and/or experience.