Penfield Search Partners
Contact: Linda Aronova – 646.882.9021 – email@example.com
Job Summary: The Lead Biostatistical Programmer I, II or III is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials, and leading project teams.
Essential Functions/Key responsibilities: Function as a Lead programmer for a compound or a group of studies performing the following functions:
- Maintain the overall timeline for his/her studies.
- Maintain the programming standards for his/her studies.
- Review standard macros used.
- Review standard datasets used.
- Discuss need for programming resources for their group of studies.
- Mentor/Train junior programmers on company systems and standards as they work on studies within their area.
- Assist junior programmers in new study set-up to help identify similar studies.
- Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.
- Check that the validation summary reports are clean of errors and warnings and show proper documentation of SAS programs.
- Review individual study CDISC validation output.
- Act as a Programming lead for a submission project under supervision of Programming management.
- Other responsibilities, as required.
Qualifications: Minimal acceptable level of education, work experience, and competency:
- Bachelors degree in Statistics, Mathematics, Computer Science or health related field. Masters is preferred.
- Minimum 5 years of programming experience using SAS Base/Stat/Macro/GRAPH in the biopharmaceutical and/or CRO industries.
- Data Management experience and knowledge of CDISC standard are highly desirable.
- Good SAS programming skills and attention to detail are essential.
- Demonstrate knowledge of regulatory biostatistics, SOPs, and guidelines.
- Highly motivated and able to work well independently.
- Strong organizational, time management, communication and project coordination and leadership skills.
- Must be able to work well under timeline pressure.
- Must be able to work on multiple tasks while coordinating others at the same time.