Senior Clinical Statistical (SAS) Programmer
The Senior Clinical Statistical (SAS) Programmer will be responsible for providing statistical support for the Biostatistics function for all clinical trials and regulatory submission, and reports to, and works under, the direction of Director/Manager, Biodata Sciences. The responsibilities of the Senior Clinical Statistical Programmer are to develop, execute, and finalize the statistical programming of Tables, listings, and Figures, adhering to strict deadlines, and within budget. This includes developing SAS or other statistical programs, development/maintenance of a SAS Macro library, analyses work, conducting quality control (QC) checks of other developers’ programs, development of CDISC/SDTM/SEND specification document. Act as a mentor for junior SAS programmers. The Senior Clinical Statistical Programmer may be asked to represent the biostatistical functions during the development/creation of CDISC/SDTM/SEND specification document to clients and other client-oriented meetings or functions.
- Provide statistical programming support for ongoing projects.
- Ensure that all FDA and international regulations are followed regarding statistical processes and procedures.
- Develop dataset specifications, Tables, Listings, and Figures programs
- Develop/Maintain/Enhance the Clinlogix Standard SAS Macro Library and programming related SOPs
- Ensure project objectives meet quality acceptance criteria.
- Responsible for maintaining study timelines within the Programming Controlled portion of the project.
- Work with external vendors to develop, test and implement technical tools to support statistical and programming needs.
- Attend relevant off-site meetings including training symposia, scientific meetings, etc. on an as-needed basis.
- Review Study design with Statistician and EDC Developers
Mentor junior SAS programmers.
- Perform additional tasks as assigned by manager.
- BS/BA (in statistics, mathematics, data sciences or related field) required.
- Strong knowledge of SAS, and other statistical software packages.
- 4-10 years of clinical research experience, with a minimum of 4 year with a pharmaceutical or medical device company or CRO or medical center.
- Understanding of CDISC (ADAM/SDTM/SEND) requirements.
- Knowledge of GCP, U.S. IND, and ICH guidelines.
- Global trial experience preferred.
- Excellent verbal and written communication skills.
- Willingness to work a flexible schedule and to travel as needed.
- The ability to travel up to 10% of the time.