Senior Biostatistician
Tasks
- Collaborate with cross functional clinical data management and regulatory teams
- Conduct safety reporting analytics and signal detection
- Create KPI reports for enrollment tracking site performance and data quality
- Create and review tables listings and figures
- Design randomization schemes
- Develop SAS macros
- Develop SDTM and ADaM datasets using CDISC standards
- Develop interactive data visualizations using Spotfire
- Develop operational dashboards for real time study monitoring
- Develop statistical analysis plans for clinical studies
- Ensure CDISC compliance across deliverables
- Generate ad hoc analytical reports for stakeholders
- Generate definexml files for regulatory submissions
- Implement automated reporting solutions
- Monitor data quality and identify trends or anomalies
- Perform advanced statistical analysis using SAS Python and R
- Perform sample size calculations
- Perform validation programming for quality assurance
- Present analytical findings to cross functional teams
- Program statistical analyses using SAS
- Review clinical protocols and amendments with statistical input
- Support risk based monitoring initiatives through analytics
- Write and review clinical study report statistical sections
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Analysis Plans | CDISC | Clinical Trial Design | Clinical trial | DefineXML | EMA submission | FDA submission | ICH Guidelines | Pinnacle 21 | Python | R | Randomization | SAS | SAS Certified Base Programmer | SAS Graph | SAS Macros | SAS Stat | SDTM | Safety reporting | Sample Size | Sample Size Calculation | Signal Detection | Spotfire | Statistical Analysis | Statistical analysis plans | Trial design
Education
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