Associate Principal Biostatistician Clinical Safety Statistics (CSS)
USA - Pennsylvania - North Wales (Upper Gwynedd), United States
R
USD 142K-224K Mid-level Full Time
Tasks
- Collaborate on drug and vaccine safety evaluation from IND to NDA and post marketing
- Collaborate with risk management safety teams to evaluate safety data
- Design develop and evaluate processes methodology and tools for product safety evaluation
- Design develop and evaluate safety data evaluation processes methods and tools
- Develop novel statistical methods or programming when needed
- Ensure deliverables meet analysis requirements standard operating procedures and regulatory requirements
- Evaluate software for planned analyses
- Participate in research for innovative statistical methods for clinical safety
- Plan and execute aggregate safety evaluations for clinical trials regulatory documents and safety inquiries
- Prepare oral and written reports and presentations for safety analysis results
- Provide statistical analysis for RMST strategic planning
- Provide statistical support and leadership for clinical safety data evaluation
- Stay current with regulatory guidance for safety data evaluation
Perks/Benefits
- 401k
- Dental insurance
- Health insurance
- Hybrid work model
- Paid Holidays
- Retirement benefits
- Sick leave
- Vacation
- Vision insurance
Skills/Tech-stack
ADaM | Bayesian analysis | Clinical Safety | Clinical Trial Design | Clinical trial | Data Processing | Drug development | Epidemiology | Integrated safety data | Meta-Analysis | R | Regulatory Compliance | SAS | SDTM | Safety Databases | Safety data | Safety signal evaluation | Scientific programming | Shiny | Signal evaluation | Statistical graphics | Statistical modeling | Survival analysis | Trial design | Visual analytics
Education
Related jobs
-
Business Data Analyst, Senior USD 113K-152KAcceptance Testing | Adaptive Randomization | Biomarker Informed Screening | CDISC | Clinical Study Protocol ReviewHybrid schedule onsite 60 percent | Training and developmentSenior-level Full TimeSan Diego, California, United States R1d ago
-
Lead Biostatistician (Clinical) USD 130K-163KADaM | Adaptive study design | Biomarker enabled study designs | Biomarker informed design | CDISC401k | Baby bonding leave | Commuter benefits | Dental insurance | Disability insuranceSenior-level Full TimeUS Remote R1d ago
-
Burden of illness | Claims data | Comparative Effectiveness | Comparative Effectiveness Research | Cost analysisCommission eligibility | Company 401k match | Company car or car allowance | Dental benefits | Employee stock purchase planSenior-level Full TimeUSA-NC-Remote, United States R2d ago
-
Principal Data Scientist USD 185K-215KAWS Lambda | Agent Orchestration | Amazon Web Services | Apache Spark | CI/CDHealth and wellness benefits | Paid time off | Professional development | Remote workSenior-level Full TimeUS - Morrisville, NC - 3900 … R2d ago
-
Technical Principal USD 216K-235KData Mining | Data Visualization | Data pipeline | Excel | PHPTelecommute allowed from anywhere in the U.S.Senior-level Full TimeMenlo Park, CA | Remote, US R5d ago
-
Principal Data Scientist USD 169K-284KA/B | A/B Testing | Ad Measurement | B testing | Causal InferenceSenior-level Full TimeRemote-USA, United States R6d ago
-
Principal Data Scientist USD 72K-97KBioinformatics | Data Quality | Data Visualization | Data pipeline | Data quality controlDental insurance | Disability insurance | ECO pass | Hybrid schedule | Life insuranceSenior-level Full TimeAurora R8d ago
-
Senior/Principal Statistician – Medical Affairs (Remote) USD 126K-179KAnalysis Plan | Biostatistics | Data Interpretation | Observational studies | RProfessional development | Remote work | Supportive cultureSenior-level Full TimeUnited States R8d ago
-
Analysis Database Specification | Analysis Plan | Biostatistics | Clinical trials | Database SpecificationCareer opportunities | Cross-functional collaboration | Permanent positionSenior-level Full TimeUnited States R9d ago
-
Principal Biostatistician FSP, Late Phase USD 115K-243KADaM | Biostatistics | CDASH | CDISC | ICH E9Career stability | Flexible schedules | Home based remote working | Technical training | Work-life balanceSenior-level Full TimeDurham, North Carolina, United States of … R10d ago
-
Principal Data Scientist - Risk Intelligence & AI USD 250K-300KAgentic AI | Apache Beam | Apache Kafka | Cloud Dataflow | Cloud Dataproc401k matching | Dental insurance | Employee assistance program | Health insurance | Life insuranceSenior-level Full TimeRemote - USA R13d ago
-
Senior Principal Biostatistician USD 108K-135KAnalysis Plan | Biostatistics | Clinical Trial Design | Clinical trial | Inferential StatisticsAnnual leave | Employee assistance program | Health insurance | Life assurance | Remote workSenior-level Full TimeUS, Blue Bell (ICON), United States R14d ago
-
Principal Biostatistician - Remote USD 130K-220K21 CFR | 21 CFR Part 11 | ADaM | Analysis Plan | BiostatisticsCareer development | Great Place to Work certified | Inclusive work environment | Remote work | Supportive teamSenior-level Full Time(Multiple States) R15d ago
-
Sr Principal Statistician USD 156K-234KAdaptive Design | Analysis Plan | Bayesian statistics | CDISC | CDISC standards401k retirement savings plan | Dental insurance | Flexible Paid Vacation | Medical insurance | Vision insuranceSenior-level Full TimeUS - Home-Based, United States R20d ago
-
Principal Statistician, Biostatistics USD 132K-198KAdaptive clinical trial design | Bayesian statistics | CDISC ADaM | CDISC SDTM | Clinical Trial Design401k retirement savings | Dental insurance | Flexible Paid Vacation | Medical insurance | Vision insuranceSenior-level Full TimeUS - Home-Based, United States R20d ago
-
Principal, Data Analytics USD 96K-145KAWS | Applied statistics | Azure | Data Architecture | Data Governance401k matching | Healthcare dental vision coverage | PTO | Paid Company Holidays | Parental leaveSenior-level Full TimeUnited States R20d ago
-
Principal Biostatistician Consultant- Hybrid (NJ/PA/DE) USD 130K-198KAnalysis Plan | Biostatistics | Clinical study | Clinical trial | RHybrid work environment | Professional development | Supportive cultureSenior-level Full TimeUnited states R20d ago
-
Principal Data Scientist, Digital & AI USD 152K-228KAgent architectures | Azure | Classification | Clustering | DBT401k match | Annual bonus | Annual equity awards | Commuting subsidy | Educational assistanceSenior-level Full Time5000 - Vertex US - Fan … R21d ago
-
Principal Biostatistician Consultant (Oncology) Remote USD 133K-180KADaM | Adaptive Design | Bayesian Methods | CDISC | Data MonitoringCareer development | Remote work | Supportive cultureSenior-level Full TimeUnited States R22d ago
-
ADaM | Analysis Plan | Biomarker Analysis | CDASH | CDISCCareer advancement | Engaging fast paced environment | Flexible schedules | Home based remote working opportunities | Job stabilitySenior-level Full TimeDurham, North Carolina, United States of … R24d ago
-
FSP Principal Statistical Programmer (Remote) USD 112K-175KADaM | Clinical data | Data Management | Data Standards | Define.xml401k retirement plan | Dental insurance | Disability insurance | Employee assistance program | Fitness reimbursementSenior-level Full TimeBridgewater, New Jersey, United States; Remote, … R26d ago
-
Principal Applied Scientist USD 190K-210KAnomaly Detection | Cloud Computing | Data Quality | Data quality assurance | Deep learning401k match | Employee assistance program | Flexible schedule | Medical/Dental/Vision insurance | Paid parental leaveSenior-level Full TimeWork From Home, United States R29d ago
-
Principal Statistician USD 115K-168KAdaptive Designs | Analysis Plan | Analysis datasets | CDISC ADaM | Clinical trialsSenior-level Full TimeRemote, REMOTE, United States R1mo ago
-
Senior Biostatistician (Remote) USD 110K-160KADaM | Analysis Plan | Biostatistics | Case Report Forms | Clinical study report401k retirement plan | Accidental death and dismemberment insurance | Dental insurance | Employee assistance program | Fitness reimbursementSenior-level Full TimeRemote, United States R1mo ago
-
Principal Biostatistician (Remote) USD 150K-200KADaM | Analysis planning | Benchmarking | Biostatistics | CDISC401k retirement plan | Accidental death and dismemberment insurance | Dental insurance | Employee assistance program | Fitness reimbursementSenior-level Full TimeBridgewater, New Jersey, United States R1mo ago