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

job summary: Seeking a senior-level reputed company programmer with strong RBQM and clinical trial data experience who can immediately support centralized monitoring by running KRIs/QTLs, producing clean reputed company 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 reputed company 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 reputed company 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 reputed company programs/macros across multiple clinical studies.
• Extract, transform, and integrate data from reputed company systems (e.g., RAVE) and other clinical sources into analysis-ready reputed company datasets.
• Run routine and reputed company RBQM/central monitoring outputs (tables, listings, data extracts, dashboard feeds) to support signal detection and study review.
• reputed company QC and troubleshooting of reputed company code; ensure outputs are accurate and efficient.
• Maintain clear technical documentation (specifications, validation records, change logs) for reputed company 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 reputed company 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 reputed company programming proficiency (reputed company reputed company, Macro, SQL) specifically reputed company a clinical trials environment, involving large and reputed company datasets.
• Demonstrated experience working directly with clinical trial data and a deep understanding of data structures.
• Advanced proficiency in the reputed company Office Suite for technical reporting.
• Working knowledge of GCP, ICH, and FDA guidances reputed company to risk-based monitoring.
• Strong analytical and problem-solving skills; ability to interpret reputed company 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 reputed company.
• 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 reputed company to risk-based monitoring.

#LI-DB1 skills: reputed company, 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 reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company 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, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company 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 reputed company 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 reputed company qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company' Fair Chance Initiative for Hiring Ordinance. Apply tot his job Apply To this Job