Job Summary (Primary function)
The Biostatistical Programmer to Principal Biostatistical Programmer 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 ad hoc analyses.
- Validate programs and associated results produced by other programming team members
- 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 under the guidance of Programming management.
- Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials.
- Collaborate with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timelines, and deliverables are met. Work independently to program for individual studies with minimal supervision.
- Work independently to program for individual studies with minimum supervision.
- Function as a Lead programmer for a project or a group of studies performing the following functions:
- Maintain the overall timeline for their studies.
- Maintain the programming standards for their studies.
- Review standard macros used.
- Review standard datasets used.
- Discuss the need for programming resources for the group of studies.
- Guide and support team members on Incyte systems and standards as they work on studies within their area.
- Assist less experienced 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.
- Serve as a mentor to less experienced programmers and as an expert to provide recommendations and solutions to complex problems.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Discover – Develop – Deliver – Collaborate
- Strong organizational, time management, communication and project coordination and leadership skills.
- Demonstrate knowledge of regulatory guidelines, including electronic submission standards.
- Good SAS programming skills and attention to detail are essential.
- Experience with data management, including familiarity with CDISC standards, is highly desirable.
- Minimum of several years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries, or equivalent skills and knowledge.
- A degree in a relevant field such as statistics or computer sciences is preferred, but equivalent practical experience will also be considered.
- Demonstrate experience in mentoring team members and providing expert recommendations and solutions to complex problems.
- Must be able to manage multiple tasks while collaborating with team members effectively.
- Must be able to effectively manage workload and prioritize tasks in a dynamic environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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