Reporting to the Biometrics Head, the candidate will be working in a cross-function team to provide the statistical expertise to multiple Research and Development programs. He/she will be responsible for leading, developing, and implementing statistical solutions to assure timely completions of Biometrics deliverables.
Responsibilities (including, but not limited to):
- Familiar with authority guidance documents such as ICH E8, E9, and E9 (R1)
- Provide leadership, guidance, and strategic input as the lead statistician on one or more projects
- Accountable for statistical aspects of clinical development plans, studies and submission activities
- Participate in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents including ICH/FDA E9 (R1)
- Oversee definition and implementation of study/project level database (including derived database), analysis and reporting standards. Coordinate with Data Management and Programming to target high quality databases and specifications at project level.
- Plan and direct study/project level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
- Conduct statistical analyses for clinical trials and provide expertise on SAS procedures
- Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
- Consider and evaluate alternative analysis methodology and data presentation techniques
- Collaborate with clinical research and development team to support publications, regulatory submissions, and other related activities including statistical innovation research
Qualifications & Experience:
- PhD in statistics/biostatistics with minimum of 8 year of experience in pharma/biotech
- Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data presentation and interpretation practices
- Strong statistical research ability for statistical methodology
- Experience with IND, NDAs, MAAs and other regulatory submissions a plus
- Ability to work effectively in a cross-functional environment
- Strong statistical programming skills using SAS, R and other relevant software
- Experience with clinical research preferred
- Good communication and interpersonal skills
- Strong project management and communication skills
- Excellent knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents
- Excellent knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials