Senior statistician Consultant- V&I (Vaccines & Infectious Diseases)
Tasks
- Calculate sample size
- Collaborate with clinical data management and programming teams
- Conduct safety efficacy and interim analyses
- Contribute to clinical study reports
- Develop and review Statistical Analysis Plans
- Develop protocol statistical input
- Ensure compliance with CDISC standards
- Guide and review statistical programmers
- Interpret clinical study results
- Lead statistical strategy for clinical trials
- Oversee statistical analyses
- Provide input for integrated analyses
- Respond to health authority queries
- Support regulatory submissions
Perks/Benefits
Skills/Tech-stack
ADaM | Analysis Plan | Biostatistics | CDISC | Clinical Trial Methodology | Clinical trial | EMA | Efficacy analysis | FDA | Integrated Analysis | Interim analysis | Protocol development | R | Regulatory Submissions | SAS | SDTM | Safety Analysis | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | TLF | Trial methodology
Education
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