Contact : Mark Maurer – [email protected]
No 3
party agencies
Job Description : The Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line.
This role leads the protocol statistical section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.
Responsibilities :
- 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 Department’s infrastructure needs.
Requirements :
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 MAA’s is highly desired.
- Ability to influence and to contribute to the advancement of innovative statistical methodology.
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