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

job summary: Seeking a senior-level SAS programmer with strong RBQM and clinical trial data experience who can immediately support centralized monitoring by running KRIs/QTLs, producing clean SAS outputs, and collaborating cross-functionally in a regulated environment. The RBQM Data Scientist supports central monitoring and risk-based quality management (RBQM) for clinical trials. This role focuses on implementing and running pre-defined KRIs, QTLs, and other risk metrics using clinical data, with strong emphasis on SAS programming to deliver robust and scalable analytics across multiple studies. Duration: 2.5 months (extension possible) Location: Remote location: Novato, California job type: Contract salary: $70.00 - 79.24 per hour work hours: 9 to 5 education: Bachelors responsibilities: The RBQM Data Scientist may perform a range of the following responsibilities, depending upon the studies' complexity and studies' development stage:

• 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.

qualifications: 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.

#LI-DB1 skills: SAS, CDISC, R Language, Good Clinical Practice (GCP), Risk Based Monitoring (RBM), Medidata, Food and Drug Administration (FDA), International Council for Harmonization (ICH) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Apply tot his job Apply To this Job