Vice President, Biometrics and Clinical Analytics
Hybrid from Oakland, CA or Cambridge, MA
R
USD 225K-253K (estimate) Executive-level Full Time
Tasks
- Build biometrics standards processes and vendors framework
- Build operational dashboards and near real time visualizations
- Conduct interim analyses
- Design clinical trials
- Develop SAPs and CSR
- Develop biometrics sourcing model
- Develop statistical sections of protocols
- Ensure GCP and ICH compliance
- Ensure data quality and integrity
- Generate and review analysis datasets and outputs
- Hire mentor and manage biometrics team
- Lead biometrics strategy
- Maintain EDC safety database data standards
- Maintain biometrics SOPs and data standards
- Manage statistical unblinding processes
- Oversee SRC DMC DSMB activities
- Oversee clinical data management and safety data
- Oversee vendor statistical programming outputs
- Partner cross functionally with clinical regulatory medical and translational teams
- Select endpoints and risk mitigation
- Select scope contract and oversee CROs and vendors
- Support aggregate safety reporting
- Support health authority interactions
- Translate statistical concepts for non technical stakeholders
Perks/Benefits
- N/A
Skills/Tech-stack
Adaptive Design | Analysis Plan | Bayesian Methods | Biostatistics | CDISC | CDISC ADaM | CDISC SDTM | CDISC standards | Clinical Trial Design | Clinical data | Clinical data management | Clinical trial | DMC | DSMB | DSUR | Data Integrity | Data Management | Data Monitoring | Data Monitoring Committee | Data Quality | Data Visualization | Dose finding | Dose finding studies | EDC | Endpoint selection | GCP | Governing meeting preparation | ICH E6 | ICH E9 | Interim analysis | Meeting Preparation | Pharmacovigilance | Power BI | Protocol development | R | R Shiny | SAS | SRC | Safety database | Spotfire | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Tableau | Trial design | Unblinding
Education
Regions
Countries
States
Cities
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