Lead Biostatisticial Programmer I-III
Job Summary (Primary function)
The Lead Biostatistical Programmer III is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials, and leading project teams.
Essential Functions of the Job (Key responsibilities)
- Conduct statistical programming work of clinical data using SAS Software.
- Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
- Generate analysis datasets according to CDISC standard and SAP.
- Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct adhoc analyses.
- Validate programs and associated results produced by other programming colleagues.
- Participate in TLF shell preparation and review, and assist statistician for SAP preparation.
- Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant.
- Develop standard SAS macros for efficient analyses of clinical data supervised by Programming management.
- Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials.
- Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timeline and deliverable are met.
- Work independently to program for individual studies with minimum supervision.
- 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 Incyte 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 necessary.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- BA/BS degree.
- Minimum 5 years of programming experience using SAS Base/Stat/Macro/GRAPH in the biopharmaceutical and/or CRO industries; a MS in statistics or computer sciences is desired.
- 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.