- R+D/ Global Development Support
- Greater Boston area
- Salary range: $190-230k base, bonus + additional benefits
A pharmaceutical company is looking to hire a Director Biostatistics position. This position reports to the Vice President, Biometrics. The Director of Biostatistics will be working in a cross-function team to deliver the statistical proficiency to multiple Research and Development programs. They will be responsible for managing, developing, and employing statistical solutions to guarantee timely completions of Biometrics deliverables.
The Director Biostatistics position will have responsibilities that include:
- Participate in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents
- 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 commonly used statistical analyses for clinical trials
- 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
The ideal candidate will have the following skill set:
- Requires a 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
- Understanding with NDAs, MAAs and other regulatory submissions a plus
- Capability to work effectively in a cross-functional environment
- Solid statistical programming skills using SAS, R and other relevant software
- Experience with clinical research preferred
- Good communication and interpersonal skills
- Strong project management skills
- Good knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents
- Good knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials