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Principal Biostatistical Programmer (PBP-LZ)

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

Responsible for processing clinical data required for stalist1cal analysis of Phase 1-111 clinical trials and lead project teams. Function as a Lead Programmer for a compound or a group of studies by reviewing programming done by others for quality, use of standards, and correctness. Ensure that the programming work done across studies in the same compound are consistent Maintain the overall timeline for assigned studies, ensuring work is completed within established limel1nes and coordinating inputs and outputs into the process to ensure that all deliveries are met on time This includes coordinating different programing modules and sub tasks to ensure the project as a whole 1s delivered on time. Maintain the programming standards for assigned studies, ensuring that for each study, standards adhere to Incyte and industry standards (Clinical Data Standards Consortiums), US regulatory (Food and Drug Administration - FDA) standards, as well as international standards (European Union. International Committee on Harmonization - ICH, Japan PMDA and China FDA). Ensure that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs. Conduct and validate analyses for correctness of statistical theory and methods, appropriateness of programming structures and logic, adherence lo Incyte coding conventions, adherence to industry naming and coding conventions, and adherence to industry reporting requirements (e.g., ICH) Provide sufficient and unambiguous documentation to allow regulator and other reviewers the ability to understand, review. and reproduce the stat1st1cal results. Review standard macros used as well as standard datasets used. Review production area after study programming is complete to make sure datasets, programs, and outputs are properly stored. Review individual study CDISC validation output. Act as a programming lead for submission projects under supervision of programming management. Discuss need for programming resources for their group of studies. including people and tools such as programming functions and macros needed to drive the analyses and output generation. Assist junior programmers in new study set-up to help identify similar studies. Mentor and train junior programmers on Incyte systems and standards as they work on studies within their area.

EDUCATION & EXPERIENCE: Master's degree or foreign equivalent in Statistics, Computer Science or related field and 3 years of experience in job offered or related occupation. Will accept Bachelor's degree followed by 5 years of experience in lieu of MS+3.

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Job Posting: 836667

Posted On: Aug 24, 2021

Updated On: Oct 12, 2021