at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
The Sr. Principal RWE Statistics Programming 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 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.
Serve as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems.
Qualifications (Minimal acceptable level of education, work experience, and competency)
BA/BS degree (MS degree in statistics or computer sciences is desired).
Minimum 8 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries.
Data Management experience including CDISC standard is highly desirable.
Good SAS programming skills and attention to detail are essential.
Demonstrate knowledge of regulatory guidelines, including electronic submission standards.
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.
Demonstrate experience serving as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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