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Senior Principal Biostatistical Programmer (SPBP-NSG)

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 assigned studies. Review standard macros and datasets used. Discuss the required programming resources for group of studies. Mentor and train junior programmers on Incyte systems and standards as they work on studies within assigned 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. Ensure 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. Responsible for quality control and validation of colleague's work and follow 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. Utilize CDISC validation program (Pinnacle 21) to check ADaM during the ADaM development stage and fix any CDISC related issues. Conduct statistical programming work of clinical data using SAS Software. Utilize SAS to generate datasets, tables, listings, and figures to be used on a daily basis. Ensure that all programs, outputs, and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs. Participate in SAP review meetings, adhering with ICH guidelines and utilizing company's Standard Safety Table Shell for all programming tasks. Generate analysis datasets according to CDISC standards 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 and 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 in SAP preparation. Attend meetings with the Standard Safety Table Shell team, and discuss 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. Create global SAS macros for repeated tasks or very complex cases so that the programming team can benefit from it for efficiency purpose. Participate in reviewing Statistical Analysis Plan and other documents essential to the conduct of statistical programming work for clinical trials. Ensure that 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, and participate in the oversight and management of programming activities to help ensure quality, timeline, and deliverables are met. Perform most of the CRO's activities, such as data transfer, reporting system issues, potential delay, etc., as well as providing suggestions for those matters. Act as a programming lead for a submission project under the supervision of the programming management. Prepare the define files by using Pinnacle 21 for independent submissions, as needed.

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Job Posting: 859817

Posted On: Oct 18, 2021

Updated On: Nov 18, 2021