Clinical Data Scientist, FDA (Sr.)
Tasks
- Analyze safety data from applicants
- Assess labeling safety claims support
- Collaborate to optimize team processes
- Conduct safety data analyses
- Draft labeling safety review support
- Draft scientific correspondence for sponsor submissions
- Lead meetings to present data quality results
- Maintain knowledge of clinical developments
- Manage SharePoint sites
- Prepare analytical summaries and scientific reports
- Review background packages and mock safety datasets
- Review drug applications for safety data adequacy
- Review scientific literature
- Summarize safety data tables figures and listings
- Support clinical review team meetings
- Verify safety data integrity and sufficiency
Perks/Benefits
Skills/Tech-stack
ADaM | Adobe Acrobat | Adverse Event | Adverse event analysis | CDISC | Causal analysis | Correlation Analysis | Event analysis | Excel | Hypothesis Testing | Longitudinal analysis | Machine Learning | Mixed-effects | Mixed-effects models | Neural Networks | Observational Study | Observational Study Design | Pharmacoepidemiology | PowerPoint | R | Random Forest | Real-World Evidence | Regression Analysis | SAS | SDTM | Safety signal detection | SharePoint | Signal Detection | Study design | Survival analysis | Time to Event | Time to event analysis | Word
Education
Regions
Countries
States
Cities
Related jobs
-
Artificial Intelligence | Critical Thinking | Data Analysis | Data Visualization | Dataset developmentProfessional developmentMid-level Full TimeGeorgetown University: Main Campus: Walsh School …5d ago
-
Associate Data Scientist - Originations USD 85K-115KData pipeline | Machine Learning | PyTorch | Python | SQL401k match | Company equipment provided | Company in person events | Company-paid medical, dental & vision | Disability benefitsMid-level Full TimeAtlanta, GA preferred, Remote R7h ago
-
Reporting Data Scientist USD 107K-160KAgile | Business Intelligence | Data Governance | Data Modeling | Data QualitySenior-level Full TimeSacramento, CA, United States10h ago
-
Staff Data Scientist, Marketing Inference USD 170K-220KA/B | A/B Testing | Attribution Modeling | B testing | Bayesian Modeling401k employer matching | Employee wellness | Free therapy | Hardware allowance | Health, dental and vision coverageSenior-level Full TimeUS - Remote R11h ago
-
Sr. Data Scientist USD 215K-220KDecision Trees | Experimentation | K-Means | Logistic Regression | Machine LearningHybrid work | On site work four days per week | Remote work one day per weekSenior-level Full TimeSan Francisco, CA R11h ago
-
Director I, Data Science, People, Purpose & Brand USD 132K-211KAPIs | Agentic Systems | Bias Mitigation | CI/CD | Cloud ComputingEmployee resource groups | Professional development | Remote work | Telecommuting | Travel up to 10%Executive-level Full TimeRemote, Remote, United States R13h ago
-
Sr Quality Data Analyst (Brand Consultant) USD 88K-115KBigQuery | Confluence | Data Analysis | Data Storytelling | Data VisualizationSenior-level Full TimeEl Segundo, CALIFORNIA, United States13h ago
-
Bioinformatics Scientist USD 85K-90KApptainer | Association studies | Bash | Bulk RNA sequencing | Cloud Platforms401k match | Dependent care assistance | Educational benefits | Employee referral bonus | Healthcare FSASenior-level Full TimeResearch Triangle Park, North Carolina13h ago
-
OT - Data Analytics Intern USD 44K-54KAIM | Correlation Analysis | Dashboarding | Data Quality | Data analyticsEntry-level InternshipBeaver, Pennsylvania, USA, 1500916h ago
-
Statistical Analyst/Programmer USD 75K-85KBioinformatics | Biostatistics | Clinical trials | Data Management | Data ValidationFull medical/dental/vision coverage | Hybrid work arrangement | Paid Holidays | Paid time off | Retirement planSenior-level Full TimePennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science Hall18h ago
-
Data Scientist USD 128K-214KAgile Development | Clustering | Data Analysis | Data Visualization | Data cleaningSenior-level Full TimeUSA-FL-Tampa, USA-FL-Fort Walton Beach18h ago
-
Senior Product Data Scientist, YouTube Shorts Creation USD 163K-237KData Modeling | Experimental Design | Machine Learning | Python | RBonus | Equity | Health insurance | Paid time offSenior-level Full TimeSan Bruno, CA, USA19h ago
-
Data Analyst USD 90K-110KArcGIS | Data Analysis | Data Quality | Data Visualization | Data reporting401k matching | Dental insurance | Flexible spending accounts | Health insurance | Paid HolidaysMid-level Full TimeWashington, DC, US20h ago
-
Data Analyst USD 105K-125KAI compliance | AI tools | ArcGIS | Data Visualization | Excel401k matching | Dental insurance | Flexible spending accounts | Health insurance | Paid HolidaysMid-level Full TimeDenver, CO, US20h ago
-
Data Analyst USD 90K-109KArcGIS | Data Analysis | Data Quality | Data Visualization | Excel401k matching | Dental insurance | Flexible spending accounts | Health insurance | Paid HolidaysMid-level Full TimeAtlanta, GA, US21h ago
-
Quant Analytics Senior Associate USD 164K-215KData Analysis | Data Manipulation | Econometrics | Fraud analytics | Performance MetricsBackup childcare | Financial coaching | Health insurance | Mental health support | Onsite wellness centersSenior-level Full TimePlano, TX, United States1d ago
-
AWS | Agentic AI | Code review | Foundation Models | GCP401k plan | Adoption reimbursement | Commuter benefits | Critical caregiving leave | Critical illness insuranceSenior-level Full Time141753-NC-Three Wells Fargo Center, Charlotte, United …1d ago
-
People Analytics Manager - Workday USD 100K-150KAdaptive Planning | Composite Reports | Correlation | Data Governance | Data QualityAccident insurance | Critical illness insurance | Dental insurance | Disability benefits | Hybrid work arrangementMid-level Full TimeRemote - Illinois, United States R1d ago
-
Data Scientist USD 116K-174KArtificial Intelligence | Databases | Machine Learning | Pandas | PythonContinuous learning | Employee ownership | Inclusive culture | MentorshipMid-level Full TimeClient Site - Washington, D.C., United …1d ago
-
Data Scientist (Level I / Level II) USD 90K-105KData Cleansing | Data Visualization | Feature Engineering | Machine Learning | Predictive Modeling401k plan | Paid Holidays | Paid time off | Sick leaveMid-level Full TimeCharlotte NC - 214 North Tryon …1d ago
-
Mid-level Full TimeHouston Headquarters, United States1d ago
-
Bioinformatics Scientist USD 85K-141KData Visualization | HPC | Java | Linux | MATLAB401k retirement plan | Certification and Learning Opportunities | Dental insurance | Employee assistance program | Employee referral programEntry-level Full TimeClient Office: Durham, NC, United States1d ago
-
Bioinformatics Scientist USD 89K-148KApptainer | Artificial Intelligence | Association studies | Bash | ChIP-seq401k retirement plan | Commuter benefits | Dental insurance | Disability insurance | Employee assistance programMid-level Full TimeClient Office: Durham, NC, United States1d ago
-
Bioinformatics Scientist USD 98K-163KChIP-sequencing | Data Analysis | Data Quality | Data quality analysis | Genomic Data Analysis401k retirement plan | Commuter benefits | Dental insurance | Disability insurance | Employee assistance programEntry-level Full TimeClient Office: Durham, NC, United States1d ago
-
Senior Business Data Analyst - Ad Operation USD 75K-126KA/B | A/B Testing | Artificial Intelligence | B testing | Bidding OptimizationComprehensive technology setup | Connectivity reimbursement | Work from home supportSenior-level Full TimeUSA - OH (Remote), United States R1d ago