Principal Biostatistician - Remote
Tasks
- Apply drug development knowledge to statistical analyses
- Create randomization and kit schedules
- Develop statistical analysis plan and interim statistical analysis plan text and shells
- Lead complex clinical research projects programs and submissions
- Manage client meetings and sponsor communications
- Perform sample size calculations
- Prepare and review statistical methods and results for CSR
- Review and develop ADAM specifications
- Review and develop statistical section of sponsor protocol
- Stay current with industry practices and regulatory guidelines
- Support DSMB by preparing and presenting unblinded statistical output
- Support regulatory submission requirements
- Use SCM tools checks in out and SharePoint
- Write white papers and blogs
Perks/Benefits
- Career development
- Great Place to Work certified
- Inclusive work environment
- Remote work
- Supportive team
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | Analysis Plan | Biostatistics | CFR Part 11 | Clinical Practice | Clinical trials | DSM B | FDA | Good Clinical Practice | IBM SPSS | ISO 27001 | ISO 9001 | Interim Statistical Analysis Plan | Part 11 | Randomization | SAS | SCM | SQC | Sample Size | Sample Size Calculation | SharePoint | Statistical Analysis | Statistical Analysis Plan | Statistical programming
Education
Roles
Related jobs
-
Biostatistician I CDNM USD 75K-109KCommunication | Data Analysis | Data Visualization | Problem Solving | Scientific writingEntry-level Full Time399 Revolution Drive Somerville (Assembly Row … R1d ago
-
Biostatistician II USD 85K-112KData Manipulation | Data Pipelines | Data Transformation | GitHub | Longitudinal datasetsRemote work opportunityMid-level Full TimeUS - Morrisville, NC - 3900 … R2d ago
-
Statistical Analyst USD 75K-85KAWS | Analysis Plans | Azure | Clinical data | Cloud ComputingEmployee assistance program | Employee wellness program | Paid Holidays | Paid time off | Professional mentoring programMid-level Full TimeDallas, TX, United States R6d ago
-
Lead Biostatistician USD 130K-163KADaM | Adaptive Design | Biomarker design | CDISC | Censoring401k benefits | Commuter benefits | Disability insurance | Employee referral program | Fertility care benefitsSenior-level Full TimeUS Remote R8d ago
-
Staff Biostatistician (Analytical Validation) USD 164K-205KAnalytical validation | Biostatistics | CLSI guidelines | Cross-functional | Cross-functional leadership401k | Baby bonding leave | Commuter benefits | Dental insurance | Disability insuranceSenior-level Full TimeUS Remote R12d ago
-
ADaM | Bayesian analysis | Clinical Safety | Clinical Trial Design | Clinical trial401k | Dental insurance | Health insurance | Hybrid work model | Paid HolidaysMid-level Full TimeUSA - Pennsylvania - North Wales … R12d ago
-
Biostatistics Scientist USD 114K-158KArtificial Intelligence | Bayesian statistics | Data Analysis | Experimental Design | Frequentist StatisticsHealth benefits | Paid Holidays | Paid time off | Parental leave | Retirement savings planSenior-level Full TimeNA-US-IA-Virtual Office, United States R13d 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 R21d ago
-
Analysis Database Specification | Analysis Plan | Biostatistics | Clinical trials | Database SpecificationCareer opportunities | Cross-functional collaboration | Permanent positionSenior-level Full TimeUnited States R22d 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 … R22d 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 R26d 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 R1mo 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 R1mo 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 R1mo 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 … R1mo 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
-
Principal Biostatistician USD 190K-231KADaM | Artificial Intelligence | Biostatistics | CDISC | CRO oversight401k match | Commuting benefits | Dental insurance | Disability insurance | Discretionary time offSenior-level Full TimeBoston, MA R1mo ago