AddressRequired Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
DESIRED EXPERIENCE/EDUCATION AND PERSONAL ATTRIBUTES:
- Ph.D. or M.S., Biostatistics or equivalent with at least 5 years of pharmaceutical, biotechnology industry experience
- Must have experience in Oncology
- Profound understanding of advanced clinical trial design and statistical analysis methodologies
- Good understanding of the big picture of an overall development program
- Capable of thinking strategically
- Excellent communication and interpersonal skills
- Ability to lead project teams, as well as work in a cross-functional team
- Strong ability to quickly capture key information from medical journal articles
- Understand regulatory requirements and good clinical practice guidelines
- Ability to multitask and prioritize work
- Good statistical programming skills using SAS and other statistical software
- Good leadership and consultation skills
Remote opportunity
Responsibilities:
- Play an active role in designing efficient clinical trials
- Collaborate with clinical trial team to support study conduct, analysis and reporting
- Serve as an influential statistical consultant to medical and development team
- Independently conduct clinical trial simulations
- Independently perform clinical, biomarker, and PK/PD data analyses
- QC and interpret clinical trial results
- Write statistical analysis plans, statistical sections of protocols, and reports
- Review relevant medical literature
- Help develop protocols, case report forms, and clinical study reports
- Develop TLF shells and review programming specs
- Engaged in clinical data review for data quality and integrity
- Act as an integral member of project team, collaborate effectively with other team members, and attend project team meetings
- Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
- Conduct quality review of statistical analyses; conduct ad hoc analyses if needed.
- Keep updated with regulatory requirements
- Support interactions with regulatory authorities
- Provided oversight to biometrics vendors
