Principal Biostatistical Programmer (PB-BR)

at Incyte Corporation in Wilmington, Delaware, United States

Job Description

Responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials, and leading project teams. Function as a lead biostatistical programmer for a compound or a group of clinical data studies. Maintain the overall timeline and programming standards for studies. Review standard macros and datasets used. Discuss need for programming resources for their group of studies. Mentor/Train junior programmers on 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. Validate programs and associated results produced by other programming colleagues. Serve as quality control to validate colleague’s work and follows up with appropriate Statistician should there be any question on the quality of output. Run CDISC validation programs e.g., OpenCDISC reports to ensure ADaM datasets are CDISC compliant. Use CDISC validation program (Pinnacle 21) to check ADaM during the ADaM developing stage to fix any CDISC related issues. Conduct statistical programming work of clinical data using SAS Software. Ensure all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs. Participate in SAP review meetings, adhere to ICH guidelines and utilize company’s “Standard Safety Table Shell” for all programming tasks. Generate analysis datasets according to CDISC standard and SAP, utilizing company’s CDISC compliance standard ADaM specs as a reference to generate analysis datasets. Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS. Conduct adhoc analyses. Work closely with statisticians to understand exactly what is needed for tables, figures and listings, and then use SAS to generate results accordingly. Participate in TLF shell preparation and review, and assist statistician for SAP preparation. Attend meetings with the “Standard Safety Table Shell”, discussing with statisticians which tables, figures and listings should be included in the final package. Draft the last section of SAP for all TFL. Ensure that the mock shells as defined in the statistical analysis plan (SAP) are properly designed to represent the data collected, analyzed and reported, and that these shells can be programmed as designed. Develop standard SAS macros for efficient analyses of clinical data supervised by Programming management. Demonstrate proficiency in writing global SAS macros for repeated tasks or very complex cases so that the programming team can benefit from it for efficiency purpose. Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials. Ensure the analyses as described are unambiguous and thus can be programmed to obtain an accurate representation of the objective of the clinical trial. Work with Clinical Research Organizations (CRO), as required, to participate in the oversight and management of programming activities to help ensure quality, timeline and deliverables are met. Act as a Programming lead for a submission project under supervision of Programming management. Prepare the define files by using Pinnacle 21 for submission independently.

Bachelor’s or foreign degree equivalent in Mathematics, Statistics, Computer Science, Pharmacy, Public Health, or related field followed by eight years of progressive, related experience. Will accept Master’s degree plus five years of related experience in lieu of a Bachelor’s plus eight years’ experience.

Email resume to Must reference job title and job PB-BR in the subject line.

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Job Posting: 1243812

Posted On: Feb 28, 2024

Updated On: Mar 29, 2024

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