CMC Statistics Director
5000 - Vertex US - Fan Pier, United States
R
USD 193K-289K Executive-level Full Time
Tasks
- Author and review statistical content for regulatory submissions
- Develop and deliver statistical training programs
- Develop approaches for PPQ CPV and SPC
- Drive adoption of advanced analytics and AI enabled statistical approaches
- Establish CMC Statistics Center of Excellence
- Evaluate emerging industry trends and best practices
- Implement Design of Experiments for development and control strategy
- Lead process characterization and optimization studies
- Lead statistical support for stability shelf life and comparability
- Perform exploratory data analysis regression multivariate and predictive modeling
- Provide statistical leadership across CMC lifecycle
- Support analytical method validation and lifecycle management
- Support investigations deviations CAPAs and quality risk analysis
Perks/Benefits
- 401k match
- Annual bonus
- Annual equity awards
- Commuting subsidy
- Educational assistance
- Hybrid work option
- Medical, dental, and vision benefits
- Paid time off
Skills/Tech-stack
AI-enabled | AI-enabled analytics | ALCOA+ | Analytical method validation | Artificial Intelligence | Capability analysis | Comparability Assessment | Continued Process Verification | Data Integrity | Design of Experiments | Digital Manufacturing | JMP | Machine Learning | Method validation | Minitab | Multivariate analysis | Performance Qualification | Predictive Modeling | Process Capability | Process Capability Analysis | Process Performance Qualification | Process Verification | Process control | Process performance | Process validation | Python | R | Regression Modeling | SAS | Shelf Life | Shelf Life Estimation | Stability analysis | Statistical Process | Statistical Process Control | Statistics
Education
Roles
Regions
Countries
States
Cities
Related jobs
-
Director/Senior Director, Product - Applied Data Science USD 245K-307KAlgorithm Development | Artificial Intelligence | Build vs Buy | Causal Inference | Data EngineeringComprehensive benefits | Equity | Hybrid work schedule | Relocation supportSenior-level Full TimeNew York, NY; Boston, MA R22h ago
-
Director of Analytics USD 140K-160KA/B | A/B Testing | Adobe Analytics | Adobe Data Collection | Attribution Modeling401k match | Commuter benefits | Dental insurance | Disability coverage | Health insuranceExecutive-level Full TimeBoston, Massachusetts, United States R1d ago
-
Associate Director, HEOR Analytics USD 175K-195KAdministrative Claims | Bias adjustment | CPT | Causal Inference | Cohort constructionMid-level Full TimeNew York, NY R1d ago
-
Director, AI & Data Science CAD 200KAI Foundry | AWS Bedrock | Agent Harness | Agentic Systems | Data CurationCompetitive benefits | Hybrid work modelExecutive-level Full Time135 W 26th Street, New York, … R1d ago
-
Agentic AI | Attribution Modeling | Bayesian Methods | BigQuery | CalibrationExecutive-level Full Time135 W 26th Street, New York, … R1d ago
-
Director, Biostatistics USD 206K-257KADaM | Analysis Plans | Bayesian statistics | Biostatistics | CRO oversightCaregiver support | Hybrid work environment | Wellness programs | Work-life balance supportExecutive-level Full TimeCambridge, MA, United States R1d ago
-
Analytics | Artificial Intelligence | Automation | Compensation analytics | Dashboards401k | Medical, dental, and vision insurance | Occasional travel | Paid time off | Remote workExecutive-level Full TimeAustin, Texas, United States of America R1d ago
-
Director, Data Science - CenterWell USD 189K-260KAI Governance | Deep learning | Experiment tracking | Generative AI | Language Processing401k retirement savings plan | Life insurance | Medical, dental, and vision benefits | Occasional travel | Paid parental and caregiver leaveExecutive-level Full TimeRemote US, United States R1d ago
-
Director of Data Engineering & AI Platforms USD 185K-315KAI Foundry | AI Platform | Agentic AI | Azure | Azure AI401k plan | Employee stock ownership plan | Flexible work schedules | Paid Holidays | Paid vacationExecutive-level Full TimeOverland Park, KS, US R1d ago
-
Director Disaster Finance Response USD 120K-155KBudgeting | Compliance | Data Analysis | Database Applications | Financial Analysis401k match | Employee assistance program | Flexible spending accounts | Health spending accounts | Long-term disabilityExecutive-level Full TimeStatewide, DC, United States R1d ago
-
Director, Computational Sciences USD 156K-296KArtificial Intelligence | Atomistic simulations | Computational Chemistry | Data Management | Drug Discovery401k | Dental insurance | Long-term incentive program | Medical insurance | Paid time offExecutive-level Full TimeNorth Chicago, IL, United States R2d ago
-
Growth AI Lead — Prospecting Science Director USD 186K-262KAPI Integration | Agent Orchestration | Artificial Intelligence | Attribution Modeling | ClayCompassionate care leave | Full Health Benefits Plans | Learning and development | Paid parental leave | Paid time offSenior-level Full TimeSeattle, WA, United States R2d ago
-
Director, AI & Agentic Engineering CAD 200KAI Foundry | AWS Bedrock | Agent Orchestration | Agentic Systems | Artificial IntelligenceHybrid workExecutive-level Full Time135 W 26th Street, New York, … R2d ago
-
Analytics | Artificial Intelligence | Bias Mitigation | Compliance | Data AnalysisClient-facing exposure | Mentorship | Remote work | Travel up to 25 percentSenior-level Full TimeRemote - Texas, United States R2d ago
-
Senior Director, AI Programmatic Sales USD 140K-175KAI Governance | Account Planning | Analytics | Artificial Intelligence | Compliance technologyCareer mobility | Enterprise learning | FlexibilitySenior-level Full TimeUSA- Illinois Remote Office, United States R2d ago
-
Senior Director, AI Programmatic Sales USD 140K-175KAI Governance | Account Planning | Artificial Intelligence | Business Development | Complex salesSenior-level Full TimeUSA- New York Remote Office, United … R2d ago
-
Director, Data Science USD 175K-210KA/B | A/B Testing | Attribution | B testing | Bandit Algorithms401k match | Dental insurance | Medical insurance | Paid Holidays | Paid parental leaveExecutive-level Full TimeRemote US, United States R2d ago
-
Director, Analytics USD 140K-165KAttribution | Closed Loop | Closed Loop Measurement | Conversion Tracking | Customer Level Data401-k match | Employee assistance program | Employee referral program | FSA & HSA options | Flexible paid time offExecutive-level Full TimeChicago, Illinois, United States; Nashville, Tennessee, … R2d ago
-
SAVP - Director of Data Engineering USD 180K-230KAWS | Account Management | Advanced Analytics | Agile | Apache SparkExecutive-level Full TimeNew York, United States R3d ago
-
Director I, Data Science Product Management USD 125K-176KAWS | Agile | Artificial Intelligence | Azure | Cloud ComputingEmployee resource groups | Professional development opportunities | Workplace flexibilityExecutive-level Full TimeRemote, Remote, United States R3d ago
-
AWS Batch | Amazon Athena | Amazon EC2 | Amazon QuickSight | Amazon Redshift401k benefits | Commuter benefits | Employee referral program | Fertility care benefits | Free employee testingExecutive-level Full TimeUS Remote R3d ago
-
Senior Director of Engineering, Generative AI USD 525K-573K3D Scene | 3D Scene Understanding | Agentic Systems | Artificial Intelligence | BenchmarkingEquity compensation | Health benefits | Onsite days Tuesday Wednesday ThursdaySenior-level Full TimeSan Mateo, CA, United States R3d ago
-
Director, Trade Analytics (Fixed Term) USD 190K-269KAdvanced Analytics | Business Intelligence | Data Governance | Data Modeling | Data QualityCompany impact networks | Learning and development | Paid Company Holidays | Paid vacation | Remote work flexibilityExecutive-level Full Time TemporaryUS345 Summit GHQ 1 Kenvue Way, … R3d ago
-
Remote Sr. Director, Healthcare Analytics USD 172K-258KCausal Inference | Claims cohort construction | Claims data | Cohort construction | Data GovernanceSenior-level Full TimeRemote CA Outside Bay Area, United … R3d ago
-
Analytics | Artificial Intelligence | Business Intelligence | Data Analysis | Generative AIExecutive-level Full TimeMcLean, VA, United States R3d ago