Job Snapshot
Location:
Delaware / Philadelphia area, DE 19801
Industry:
Biotechnology
Pharmaceutical
Education:
Graduate Degree
Experience:
At least 2 year(s)
Contact Information
Description
Our client is a drug discovery and development company with a growing pipeline. They have asked us to assist them in their search for a Senior Manager Biostatistics.
The Senior Manager Biostatistics will be responsible for providing statistical supports to drug development programs, including: statistical input of protocols, writing statistical analysis plans, performing programming and planned statistical analyses and producing summary tables, listings and graphs, interpreting study results and writing statistical summary reports of study results.
Responsibilities will include:
- Provide statistical input to study protocols
- Develop statistical analysis plan
- Participate in pre-IND and NDA activities
- Manage and coordinate CRO project teams and activities to conduct and complete projects on time
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources
- Perform programming and planned statistical analyses and produce summary tables, listings and graphs
- Interpret study results and write statistical summary reports of study results
- Assist in writing relevant sections of the clinical study report
- Participate in the development and enforcement of SOPs and guidelines
Requirements
We seek candidates with these minimum requirements:
- Masters degree in statistics or other relevant area with Ph.D. preferred
- A minimum of 2 – 6 years of experience in the pharmaceutical or biotechnology industries
- Broad knowledge of biostatistics, FDA/EMEA guidelines and drug development process
- SAS programming skill required.
Do you have the experience we seek and want to advance your career with a growing biopharmaceutical company? If so, please email your resume as a Word attachment to [Click Here to Email Your Resumé], reference code 2303-CB. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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