FSP Principal Biostatistician- Early Phase Clinical Development(PK)
Durham, North Carolina, United States of America
R
USD 115K-243K Senior-level Full Time
Tasks
- Collaborate with data management and clinical pharmacology teams
- Collaborate with multidisciplinary project teams
- Contribute to clinical study reports
- Create and review TLF specifications
- Create and review randomizations
- Create and review sample size calculations
- Create and review statistical analysis plans
- Monitor internal and CRO project activities
- Perform inferential analyses
- Provide statistical input to study synopses and protocols
- Review eCRF and data management documents
- Review study results for accuracy
- Supervise programmers for analysis dataset specifications and output specifications
- Support IND activities
- Support exploratory analyses
- Validate key data derivations
- Write statistical sections of clinical trial protocols
Perks/Benefits
- Career advancement
- Engaging fast paced environment
- Flexible schedules
- Home based remote working opportunities
- Job stability
- Long term project continuity
- Long-term engagements
- Redeployment opportunities
- Research opportunities
- Tailored development curriculum
- Technical training
- Work-life balance
Skills/Tech-stack
ADaM | Analysis Plan | Biomarker Analysis | CDASH | CDISC | Clinical trial | Clinical trial protocol | Data Derivation | Data derivation validation | Exploratory analysis | ICH GCP | ICH GCP regulatory guidance | Inferential analysis | Noncompartmental PK | Programming | R | Randomization | Regulatory guidance | SAS | SDTM | Sample Size | Sample Size Calculation | Simulation | Statistical Analysis | Statistical Analysis Plan | Statistical modeling | TLF specification
Education
Regions
Countries
States
Cities
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