Senior Statistical Programmer

Statminds, LLC   King Of Prussia, PA   Full-time     Information Services / Technology (IT)
Posted on January 19, 2023

Senior Statistical Programmer

Duties: Experience in implementing CDISC SDTM & ADaM in clinical trials analysis, and all aspects of SAS programming language used in clinical trials programming; Use statistical concepts in support of analyses & reporting of clinical trials; Experience in advanced statistical methods using SAS & R; Guide internal programmers or perform programmatic review of Study Date Tabulation Model (SDTM) & analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor, ensure vendor programming implementation, & expedite preparation of regulatory submissions; Plan review Case Report Form (CRF) annotation & SDTM dataset, identify data inconsistencies, support data review, review analysis dataset specifications, ensure correct interpretation of SAP, develop independent programs to validate study level analysis dataset and TLFs, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package; Develop programming submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission Q&As, perform ad-hoc & exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting; Contribute to CRF & SDTM standard development, develop, implement, maintain SDTM, ADaM dataset and TLF standard, develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis; Generate results by using statistical procedures like PROC MEANS, PROC FREQ, PROC SQL, PROC IMPORT/EXPORT, PROC COMPARE, PROC TRANSPOSE, PROC GCHART, PROC GPLOT & PROC REG. Skills: CDISC, SDTM, ADaM, SAS programming, R, SAP, PROC MEANS, PROC FREQ, PROC SQL, PROC IMPORT/EXPORT, PROC COMPARE, PROC TRANSPOSE, PROC GCHART, PROC GPLOT & PROC REG. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. Send Resume to Statminds, LLC, 501 Allendale Rd, Suite 202, King of Prussia, PA, 19406.

Requirements: Master’s degree in any related field of study with 1 year of experience in a job title with similar duties and skills.

Send resume to Statminds, LLC, 501 Allendale Rd, Suite 202, King Of Prussia, PA, 19406.