Principal Biostatistician

Play a major role in designing efficient trials, independently conduct clinical, PK/PD, and biomarker data analyses, and proactively provide substantial contributions to overall clinical development planning. This person will have strong technical expertise, be able to proactively add value to the development of clinical and regulatory strategies, and may also mentor junior biostatisticians.DUTIES & RESPONSIBILITIES- Play a leading role in designing efficient clinical trials
- Provide visible contributions to clinical development strategies
- Independently conduct statistical simulations if needed
- Independently perform clinical, biomarker, and PK/PD data analyses
- Interpret statistical analysis 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
- Serve as an influential statistical consultant and provide leadership to clinical development teams when needed
- 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
- Review and provide feedbacks for Data Integrity Plans
- Keep updated with regulatory requirements including good clinical practice guidelines
- Interact effectively with regulatory authorities
- Mentor junior biostatisticiansQUALIFICATIONS- M.S. in Biostatistics with at least 6 years of pharmaceutical, biotechnology, or equivalent experience, or Ph.D. in Biostatistics or equivalent with at least 2.5 years of pharmaceutical, biotechnology, or equivalent experience.

- Profound understanding of advanced clinical trial design and statistical analysis methodologies
- Excellent communication and interpersonal skills
- Ability to lead project teams, as well as work in a cross-functional team
- Successfully completed several large or complex projects
- 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 coaching and mentoring skills