Senior Biostatistician
Tasks
- Comply with ICH standards and FDA regulations
- Contribute randomization methodology
- Contribute to bid proposals and budget review
- Contribute to manuscripts for publication
- Create ADaM datasets
- Create SDTM datasets
- Create derived datasets
- Defend bid in meetings
- Develop test run SAS programs
- Extract trial data summaries and listings
- Format report documents and tabulations
- Identify system and process improvements
- Implement process solutions
- Liaise with sponsors and internal departments
- Maintain knowledge of statistical software and regulatory guidance
- Maintain program and validation documentation
- Maintain validation and testing documentation
- Manage statistical project support
- Prepare final reports tables listings figures
- Produce ad hoc data summaries
- Provide statistical consultancy
- Review analysis plans
- Review study designs
- Review study reports
- Review tables figures listings shells
- Support clinical trial design
- Support quality assurance and audits
- Support statistical design and analysis policies
- Test SAS macros
- Validate clinical study datasets
- Validate software
- Write Statistical Analysis Plans
- Write derived dataset specifications
- Write reports
Perks/Benefits
- N/A
Skills/Tech-stack
ADaM | Analysis planning | CDISC | CDISC datasets | Clinical Trial Design | Clinical data | Clinical data management | Clinical trial | Data Management | Data Validation | Derived Datasets | ICH | Randomization | SAS | SAS Macros | SAS programming | SDTM | Statistical Reporting | Tables figures listings | Trial design
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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