Principal Biostatistician Consultant (Oncology) Remote
Tasks
- Collaborate with cross functional clinical data management programming regulatory and medical teams
- Contribute to regulatory submissions and respond to health authority queries
- Design and review statistical methodologies for efficacy and safety analyses
- Develop statistical analysis plans protocols and clinical study reports
- Mentor junior statisticians and provide technical guidance
- Oversee analysis datasets SDTM and ADaM and TLFs
- Provide statistical leadership for oncology clinical trials
- Provide strategic input on study design endpoint selection and sample size calculations
- Support interim analyses data monitoring committee activities and adaptive designs
Perks/Benefits
Skills/Tech-stack
ADaM | Adaptive Design | Bayesian Methods | CDISC | Data Monitoring | Data Monitoring Committee | Immuno-oncology | Interim analysis | R | SAS | SAS TLF | SDTM | Survival analysis | Time to Event
Education
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