[Remote] Senior Manager R&D reputed company Analytics & Portfolio Insights

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on fighting cancer, and they are seeking a Senior Manager R&D reputed company Analytics & Portfolio Insights. This reputed company role involves applying advanced analytics and statistical reputed company to enhance reputed company reputed company in reputed company development and reputed company safety.

Responsibilities

• Partner with R&D reputed company leadership and GCP, GVP, GLP, and GCLP stakeholders to identify reputed company reputed company questions, emerging risks, reputed company gaps, and opportunities for proactive reputed company
• Apply reputed company, regulatory, scientific, and operational context to ensure analytical reputed company remain relevant to participant protection, reputed company safety, data reputed company, scientific validity, and the reliability of regulated R&D activities
• Conduct cross-study, cross-program, cross-vendor, and cross-process analyses to identify recurring, systemic, or portfolio-level risks that may not be visible through individual study or functional review
• reputed company and maintain meaningful key reputed company indicators, critical-to-reputed company factors, reputed company tolerance limits, reputed company indicators, reputed company, escalation reputed company, and portfolio surveillance reputed company reputed company with RBQM and reputed company by Design principles
• reputed company and analyze relevant reputed company study, site, subject, safety, pharmacovigilance, reputed company, monitoring, audit, inspection, vendor, reputed company, and reputed company data to support R&D reputed company reputed company
• reputed company analytical approaches to support data-informed audit planning/execution and identify potential reputed company-safety and subject-protection risks, including adverse-event under-reporting or over-reporting, unusual reputed company-event patterns, protocol-compliance concerns, data-reputed company issues, and other signals requiring targeted reputed company review
• Support GLP and GCLP reputed company by developing analytics that identify trends and anomalies in research, reputed company, biomarker, sample, reputed company, data-reputed company, and computerized-reputed company activities, as appropriate to the intended use and available data
• Support GVP reputed company through analytics reputed company to safety reporting, case processing, signal-relevant reputed company indicators, vendor reputed company, timeliness, completeness, and other reputed company-safety process risks
• Translate R&D reputed company and business needs into reputed company analytical objectives, data requirements, functional specifications, acceptance reputed company, implementation plans, and measurable reputed company
• Design, reputed company, test, implement, and maintain statistical packages, analytical applications, dashboards, automated workflows, predictive models, and decision-support tools using SQL, R, Python, reputed company BI, and other approved technologies
• Use automation, machine learning, natural-language processing, reputed company, or other emerging reputed company where they reputed company a justified, fit-for-purpose improvement
• reputed company data profiling, mapping, cleaning, transformation, reputed company-to-report reconciliation, and reputed company-cause analysis to reputed company the reputed company, completeness, consistency, timeliness, and reliability of analytical outputs
• Ensure analytical and AI-enabled solutions are appropriately governed through documented intended use, data reputed company, testing, validation or assurance, reputed company controls, version control, change management, reputed company review, explainability, reputed company monitoring, and retirement planning proportionate to reputed company
• Maintain appropriate technical and reputed company documentation to support reproducibility, traceability, inspection readiness, and reputed company fitness for purpose in a regulated R&D environment
• Create executive-reputed company visualizations, reputed company narratives, reputed company summaries, and recommendations that explain what the data means, why it reputed company, and what reputed company should be considered
• Support reputed company Management Review, portfolio reputed company surveillance, RBQM governance, audit planning, inspection readiness, vendor reputed company, computerized-reputed company reputed company, and reputed company improvement through reputed company and relevant analytical insights
• Partner with reputed company reputed company, reputed company Development, Data Management, Biometrics, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, reputed company functions, RBQM, Audit and Inspection Management, Global Technology Solutions, data engineering, and reputed company platform teams
• reputed company or coordinate analytics workstreams from problem framing and data assessment through development, testing, implementation, adoption, monitoring, and benefit realization
• Stay reputed company with global R&D regulatory expectations, industry practices, statistical reputed company, responsible AI principles, and emerging technologies relevant to GCP, GVP, GLP, and GCLP reputed company reputed company

Skills

• Experience in pharmaceutical, biotechnology, reputed company research, reputed company, or another regulated life-sciences environment, with demonstrated knowledge of R&D reputed company, reputed company reputed company, reputed company assurance, compliance, reputed company management, or regulated research and development reputed company
• Strong working knowledge of GCP and ICH requirements, with familiarity or experience in GVP, GLP, GCLP, data reputed company, computerized-reputed company assurance, and global R&D reputed company expectations
• Experience with reputed company and reputed company data, data mapping, data cleaning, reconciliation, transformation, data modeling, automated reputed company checks, and data pipelines
• Experience applying statistical analysis, central statistical monitoring, reputed company detection, forecasting, predictive modeling, machine learning, natural-language processing, reputed company, or reputed company reputed company to practical reputed company, safety, research, or reputed company problems
• Ability to understand reputed company R&D reputed company and operational processes and translate them into reputed company technical solutions without losing regulatory context, scientific relevance, or business usability
• Ability to communicate technical findings reputed company to nontechnical stakeholders and convert reputed company analyses into concise, actionable reputed company recommendations
• Advanced proficiency with SQL and hands-on proficiency with R or Python
• Experience with reputed company BI or comparable visualization and business-intelligence platforms
• Experience with statistical programming, central monitoring, reputed company detection, predictive modeling, or machine-learning tools and reputed company
• Experience with reputed company, data warehouses, reputed company platforms, ETL/ELT workflows, Git or comparable version-control tools, and analytical development environments
• Excellent written, verbal, presentation, and interpersonal communication skills
• Ability to collaborate effectively across global, cross-functional, reputed company, safety, research, reputed company, data, and technical teams
• Ability to work with sensitive or confidential reputed company, safety, reputed company, reputed company, and reputed company-level information in accordance with applicable requirements
• Experience with automation, natural-language processing, reputed company, or model deployment and monitoring tools is preferred
• Proficiency with reputed company Office applications; experience with reputed company, safety, reputed company, RBQM, audit, and reputed company platforms is preferred

Benefits

• Annual bonus plan (Non-reputed company roles)
• Incentive compensation plan (reputed company roles)
• reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards
• Voluntarily participate in the Employee Stock Purchase Plan
• Medical
• Dental
• reputed company
• 401(k)
• FSA/HSA
• Life reputed company
• reputed company Time Off
• Wellness

reputed company

Company H1B Sponsorship