Associate Director Biostatistics
Associate Director Biostatistics
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description
No 3rd 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 crossfunctional 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 Departments infrastructure needs.
Requirements:
- 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.
Required Experience:
Director
Employment Type
Full-Time
