Principal Biostatistician
Warsaw, Masovian Voivodeship, Poland
PLN 271K-329K (estimate) Senior-level Full Time
Tasks
- Analyze clinical data
- Conduct departmental training
- Design clinical studies
- Develop clinical protocol content
- Develop statistical analysis plan
- Ensure statistical quality and validity
- Interpret clinical study results
- Lead biostatistics activities
- Maintain project timelines and financials
- Maintain statistical documents
- Mentor junior biostatisticians
- Oversee statistical output
- Plan and coordinate statistical analyses
- Provide guidance for pivotal outputs
- Provide specifications for statistical outputs
- Represent Biostatistics in meetings
- Review ADaM datasets
- Review ADaM specifications
- Review SDTM datasets
- Review SDTM specifications
- Review TLFs
- Review statistical documents
- Support IDE and PMA submissions
- Support IND NDA BLA submissions
- Support audits
- Support bid defenses
- Support budget reviews
- Support final CSR contributions
- Support interim analysis reports
- Support proposal input
Perks/Benefits
Skills/Tech-stack
ADaM | Analysis Plan | BLA | Clinical Trial Design | Clinical trial | Clinical trials | ICH | ICH E6 | IDE | IND | Logistic Regression | Mixed Models | NDA | PMA | Regulatory Submissions | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | Survival analysis | TLF | Trial design
Education
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