Statistical Programmer

Jobvertise.com - Jobboard; Bridgewater (MA); Remote; USD 149,000; Full time

Job summary

A leading clinical research organization is seeking a Statistical Programmer to develop and validate datasets for clinical studies. The role involves quality control, dataset specifications, and compliance with CDISC standards, requiring extensive experience in statistical programming and clinical trials.

Qualifications

• 6 years of progressive statistical programming experience.
• Experience in Clinical trial statistical programming and CDISC.
• Proficient in SDTM and ADaM datasets.

Responsibilities

• Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE.
• Perform quality control (QC) review of documents and datasets.
• Lead programming teams for regulatory submission activities.

Skills

Statistical Programming

Quality Control

CDISC Compliance

Dataset Validation

Education

Bachelor's degree in Public Health, Statistics, Biostatistics, or Computer Sciences

Job description

Everest Clinical Research Corporation – Bridgewater, NJ

Statistical Programmer will develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project specific requirements. Perform quality control (QC) review of these documents prepared by others. Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE. Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) QC checklists. Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client. Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others. Participate and/or lead programming teams in support of product regulatory submission related activities. Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers. Develop new macros and utilities. Requires a bachelor’s degree in public health, Statistics, Biostatistics, or Computer Sciences and 6 years of progressive statistical programming experience which includes: 6 years of experience in Clinical trial statistical programming;6 years of experience in SDTM and ADaM dataset; 6 years of experience in Tables, listings, and graphs (TLGs) for Clinical Study Reports (CSRs); 6 years of experience in Integrated Summary of Safety/Efficacy (ISS and ISE); and 6 years of experience in CDISC. Telecommuting and working from home permitted. Salary $148,481.84/year. Apply directly at https://www.jobpostingtoday.com/application/15473/applyand reference Job # 15473.

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