Senior Biostatistician - Remote (US)
Tasks
- Create randomization and kit schedules
- Create statistical protocol sections
- Develop statistical analysis plans
- Lead biostatistics projects
- Manage client meetings and CRM activities
- Perform sample size calculations
- Prepare and review CSR statistical sections
- Provide ICH guideline based statistical input
- Provide unblinded statistical outputs for DSMB
- Resolve comments with client and programmers
- Review ADAM and TLFs
- Review protocol statistical section
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical trial | Drug development | FDA | GCP | ICH Guidelines | MS Office | Part 11 | Project Management | Randomization | SAS | SAS Base | SAS Macro | SDTM | Sample Size | Sample Size Calculation | TLF | TLG
Education
Related jobs
-
Biostatistician USD 70K-100KBiomarker Analysis | Clinical Trial Design | Clinical trial | Data Management | Data QualityDental insurance | Educational benefits | Hybrid schedule | Life insurance | Medical insuranceSenior-level Full TimeAlbuquerque, United States; Albuquerque, NM, United … R2d ago
-
Analysis Database Specification | Analysis Plan | Biostatistics | Clinical trials | Database SpecificationSenior-level Full TimeUnited States R2d ago
-
Sr Biostatistician USD 101K-152K21 CFR | 21 CFR Part 11 | ANOVA | Analysis Plan | CFR Part 11401k contributions | Continuing education and training | Employee assistance program | Employee resource groups | Employee service corpSenior-level Full TimeREMOTE- Illinois, United States R9d ago
-
Principal Biostatistician RWE (NA Only) - with PASS (Post Authorization Safety Surveillance) Experience USD 80K-175KAnalysis Plan | Causal Inference | Cluster Analysis | Comparative Effectiveness | Comparative Effectiveness Research401k match | Company car or car allowance | Employee stock purchase plan | Flexible paid time off | Health benefitsSenior-level Full TimeUSA-WA-Remote, United States R9d ago
-
FSP Principal Biostatistician, Safety Analytics USD 111K-309KADaM | Analysis Plan | Biostatistics | CDASH | CDISCCareer trajectory | Engaging fast paced environment | Flexible schedules | Home based remote working opportunities | Job stabilitySenior-level Full TimeDurham, North Carolina, United States of … R9d ago
-
ADaM | Adaptive Design | Analysis Plan | BLA | Bayesian MethodsProfessional development | Remote work | Supportive cultureSenior-level Full TimeUnited States R13d ago
-
Principal Biostatistician USD 123K-233KBiostatistical Quality Assurance | Clinical drug development | Clinical operations | Clinical trials | Data ManagementRemote workSenior-level Full TimeMorrisville, NC, US R19d ago
-
Senior Biostatistician USD 130K-130KADaM | Analysis Plans | Biostatistics | Case Report Forms | Clinical trials401k retirement plan | Employee assistance program | Fitness reimbursement | Life insurance | Long-term disabilitySenior-level Full TimeRemote, United States; Bridgewater, New Jersey, … R19d ago
-
Clinical Biostatistician I USD 86K-129KAnalysis Plan | Analytical Validity | Biostatistics | Clinical Predictive Modeling | Clinical UtilityDental insurance | Health insurance | Paid caregiver leave | Paid parental leave | Paid time offMid-level Full Time5505 Endeavor Lane, United States R23d 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 R1mo ago
-
ADaM | Analysis Plan | Biostatistics | CDISC | Clinical Trial MethodologyCareer opportunities | Client facing work experience | Professional development | Supportive cultureSenior-level Full TimeUnited States R1mo 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 R1mo 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 … R1mo ago