Everest Clinical Research Services Inc.
Statistical Programmer I
Everest Clinical Research Services Inc., Trenton, New Jersey, United States,
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a
Statistical Programmer
for our August Research location in
Warsaw, Poland , with opportunities to work remotely from a home-based office in accordance with our Work from Home policy.Key Accountabilities:Under supervision, may develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents based on Statistical Analysis Plan (SAP), Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements.Program and validate SDTM and ADaM datasets following approved dataset specifications; perform CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings.Develop SAS programs to generate and validate statistical output reports of trial data based on the SAP and TLGs mock-up shells.Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations, as well as other data analysis and reporting needs such as regulatory required safety reports, ad-hoc requests, and exploratory data analyses.Develop and maintain SAS programs to perform database integrity checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review.Support data acquisition of non-CRF data by developing SAS programs to reconcile the CRF and non-CRF data and performing data integrity checks of the non-CRF data.Document data and programming information in accordance with Everest company SOPs and WIs; and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.Achieve a high rating for each of the defined Everest company and trial Sponsor-specific statistical programming key performance indicators.Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements when applicable.Comply to Everest company-specific and clinical trial Sponsor-specific training requirements.Qualifications and Experience:A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences, with SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred; with exposure/experience in clinical trial statistical programming and/or data analysis is desirable.We thank all interested applicants, however, only those selected for an interview will be contacted.Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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Statistical Programmer
for our August Research location in
Warsaw, Poland , with opportunities to work remotely from a home-based office in accordance with our Work from Home policy.Key Accountabilities:Under supervision, may develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents based on Statistical Analysis Plan (SAP), Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements.Program and validate SDTM and ADaM datasets following approved dataset specifications; perform CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings.Develop SAS programs to generate and validate statistical output reports of trial data based on the SAP and TLGs mock-up shells.Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations, as well as other data analysis and reporting needs such as regulatory required safety reports, ad-hoc requests, and exploratory data analyses.Develop and maintain SAS programs to perform database integrity checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review.Support data acquisition of non-CRF data by developing SAS programs to reconcile the CRF and non-CRF data and performing data integrity checks of the non-CRF data.Document data and programming information in accordance with Everest company SOPs and WIs; and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits.Achieve a high rating for each of the defined Everest company and trial Sponsor-specific statistical programming key performance indicators.Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements when applicable.Comply to Everest company-specific and clinical trial Sponsor-specific training requirements.Qualifications and Experience:A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences, with SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred; with exposure/experience in clinical trial statistical programming and/or data analysis is desirable.We thank all interested applicants, however, only those selected for an interview will be contacted.Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
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