Associate Director Biostatistics - Remote
Penfield Search Partners
- Fairfield, CT
- Permanent
- Full-time
- Lead complex clinical trials or indication corresponding to one or several compounds in development.
- Represents Biostatistics as a member of cross functional teams, accountable for statistical aspects of statistical design, study setup, execution, analysis and reporting of clinicals.
- Manage the timelines and oversee the quality of statistical analyses by CRO or internal teams.
- Undertake new and highly complex issues requiring advanced analytical thought with minimal supervision.
- Support global submission deliverables as needed including responses to health authority queries, advisory committee meeting preparation, etc
- Provide statistical support for the Biometrics Departments infrastructure needs.
- MS in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience or a PhD in Statistics/Biostatistics with more than 6 years of relevant pharmaceutical experience
- Knowledge of pharmaceutical environment and regulatory requirements
- Comprehensive knowledge and understanding of advanced statistical concepts and techniques applicable to Clinical Research
- Excellent project management, interpersonal and communication skills
- Experience with NDAs, and MAAs is highly desired.
- Ability to influence and to contribute to the advancement of innovative statistical methodology.