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Randstad USA · 2 days ago

Data Scientist, Risk-Based Quality Management (RBQM) - REMOTE

United States

Contract

Remote

Mid, Senior Level

$70/hr - $79.24/hr

3+ years exp

Randstad USA is seeking a senior-level SAS programmer with strong RBQM and clinical trial data experience. The RBQM Data Scientist will support central monitoring and risk-based quality management for clinical trials by implementing and running pre-defined KRIs, QTLs, and other risk metrics using clinical data.

ConsultingHuman ResourcesInformation TechnologyRecruiting

H1B Sponsor Likely

Responsibilities

Implement and maintain pre-defined KRIs, QTLs, and triggers using robust SAS programs/macros across multiple clinical studies

Extract, transform, and integrate data from EDC systems (e.g., RAVE) and other clinical sources into analysis-ready SAS datasets

Run routine and ad-hoc RBQM/central monitoring outputs (tables, listings, data extracts, dashboard feeds) to support signal detection and study review

Perform QC and troubleshooting of SAS code; ensure outputs are accurate and efficient

Maintain clear technical documentation (specifications, validation records, change logs) for all RBQM programs and processes

Collaborate with Central Monitors, Central Statistical Monitors, Data Management, Biostatistics, and Study Operations to understand requirements and ensure correct implementation of RBQM metrics

Qualification

SAS programmingClinical trial dataRisk-Based Quality ManagementCDISC standardsClinical Practice (GCP)Data ManagementAnalytical skillsMicrosoft Office SuiteEffective communicationTeamwork skillsProblem-solving skillsCollaboration

Required

Advanced degree (PhD, MS) or BA/BS in Statistics, Biostatistics, Computer Science, Data Science, or a related Life Sciences discipline

Extensive clinical development experience (Programming, RBQM, or Data Management) with the following minimums: PhD +3 years, MS +5 years, or BA/BS +8 years

Advanced SAS programming proficiency (Base SAS, Macro, SQL) specifically within a clinical trials environment, involving large and complex datasets

Demonstrated experience working directly with clinical trial data and a deep understanding of data structures

Advanced proficiency in the Microsoft Office Suite for technical reporting

Working knowledge of GCP, ICH, and FDA guidances related to risk-based monitoring

Strong analytical and problem-solving skills; ability to interpret complex data and risk outputs

Effective communication and teamwork skills; comfortable collaborating with cross-functional, global teams

Ability to manage multiple programming tasks and deliver high-quality work in a fast-paced environment

Preferred

Direct hands-on experience with Medidata Rave EDC

Practical knowledge of CDISC standards, specifically SDTM and CDASH

Familiarity with R, Python, or JavaScript, particularly regarding clinical data visualization platforms

Working knowledge of GCP, ICH, and FDA guidances related to risk-based monitoring

Benefits

Medical

Prescription

Dental

Vision

AD&D

Life insurance offerings

Short-term disability

401K plan

Company

Randstad USA

Glassdoor3.8

Randstad US is a wholly owned subsidiary of Randstad Holding nv, a global provider of human resources solutions.

Founded in 1998

Atlanta, Georgia, USA

1001-5000 employees

http://randstadusa.com

H1B Sponsorship

Randstad USA 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

2023 (754)

2022 (776)

2021 (1143)

2020 (1749)