Senior Biostatistician FSP
Tasks
- Author SOPs and work instructions
- Collaborate with CROs and vendors
- Create analysis datasets and TLG specifications
- Develop CDISC aligned outputs
- Develop data transfer specifications
- Develop programming standards and macros
- Develop statistical analysis plans
- Develop study protocols
- Ensure compliance with FDA regulations and GCP
- Execute statistical analyses
- Generate ADaM specifications
- Interpret statistical results
- Perform sample size calculations
- Prepare clinical study reports
- Prepare integrated summaries for submissions
- Present statistical methodology and results
- QC efficacy and safety tables
- Review CRFs and data review guidelines
- Support clinical studies
Perks/Benefits
Skills/Tech-stack
ADaM | Analysis Plan | CDISC | CRF | Clinical Practice | Clinical trials | Dataset QC | Efficacy tables | Electronic submissions | FDA Regulations | Good Clinical Practice | Protocol development | QC | R | SAS | SOP Development | Safety tables | Sample Size | Sample Size Calculation | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Statistics | Study Protocol | Study protocol development | TLG
Education
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