Centralized Statistical Monitoring, Senior Manager (Clinical Trials)

Location: United States - Remote

Salary: $154,104.15–$208,493.85 annually

Company

hirify.global is a biotechnology company developing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Own the centralized statistical monitoring analysis system, signal framework, analytical workflows, and related business processes.
• Lead statistical deliverables and provide operational, technical, and business leadership for centralized monitoring across clinical studies.
• Shape the strategy, roadmap, standards, operating procedures, and governance model for centralized statistical monitoring within RBQM.
• Lead system lifecycle activities, including requirements definition, prioritization, user acceptance testing, validation, release readiness, and continuous improvement.
• Develop and evaluate monitoring signals using outlier detection, trend analysis, anomaly detection, risk indicators, comparative analytics, and QTL approaches.
• Lead, coach, and develop statisticians while partnering with Statistics, Digital Technology, Programming, Data Management, Clinical Operations, Quality, and RBQM teams.

Requirements

• Doctorate with 4 years, master's degree with 8 years, or bachelor's degree with 10 years of relevant experience in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline.
• Experience in statistical monitoring, clinical development, biopharmaceutical research, RBQM, QTLs, Quality by Design, or clinical trial quality oversight.
• Experience developing, validating, implementing, or reviewing statistical monitoring signals or regulated analytical deliverables in production.
• Strong statistical programming and analytical skills using SAS and/or R.
• Experience with analytical system ownership, software development lifecycle activities, people leadership, cross-functional initiatives, and operating procedures.
• Strong communication skills and the ability to work in a globally dispersed, cross-cultural environment.

Nice to have

• Experience with Bayesian methods, hierarchical modeling, machine learning, advanced analytics, R Shiny, or business intelligence platforms.
• Understanding of regulatory and industry trends related to RBQM, clinical trial quality, and centralized monitoring.

Culture & Benefits

• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for this role is not guaranteed.