Everest Clinical Research · 1 day ago
Statistical Programmer II
Bridgewater, NJ
Full-time
Hybrid
Mid LevelEverest Clinical Research is a full-service contract research organization providing clinical research services to the pharmaceutical and biotechnology industries. They are seeking a Statistical Programmer II to develop and validate datasets, support data acquisition, and ensure compliance with industry standards and regulations.
Pharmaceutical
Responsibilities
Under supervision, may develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents (e.g., define.xml, reviewer’s guide) 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 (Integrated Summary of Safety and Integrated Summary of Efficacy), as well as other data analysis and reporting needs such as regulatory required safety reports (e.g. Development Safety Update Report, 120 Day Safety Update, etc.), 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
Develop SAS programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews (safety, missing data, trending and signaling, etc.)
Develop SAS programs to generate Patient Profiles to support trial subject case review activities
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
Develop and provide expertise in other programming and system administration areas when required
Qualification
Required
A Master's or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences
SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred
Exposure/experience in clinical trial statistical programming and/or data analysis is desirable
Company
Everest Clinical Research
Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields
Founded in 2004
501-1000 employees
H1B Sponsorship
Everest Clinical Research has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (4)
2023 (4)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$0.1MKey Investors
FedDev
2020-12-07Acquired
2019-08-18Grant· $0.1M
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