Senior Biostatistics Consultant â FDA Statistical Review Support (Part-Time)
Senior Biostatistics Consultant â FDA Statistical Review Support (Part-Time)
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Job Description
Job Description
Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates
Job Title:Senior Biostatistics Consultant FDA Statistical Review Support (Part-Time)
Location:Remote (U.S.-based)
Commitment:Part-time (10 hours/month flexible)
Duration:Ongoing consulting engagement
Start Date:ASAP
FDA Submissions Experience a Must
Overview:
We are seeking an experienced Senior Biostatistics Consultantwith prior FDA experience to provide ad hoc statistical review supportfor regulatory inquiries. This consultant will serve as an extension of our current statistical leadership team assisting in the preparation and response to FDA statistical requests particularly in the ophthalmologytherapeutic area.
This is a highly specialized role ideal for a former FDA Statistical Reviewerwho understands regulatory expectations submission review processes and has a track record of supporting ophthalmology-related drug applications.
Key Responsibilities:
- Provide expert biostatistical support in response to FDA inquiries and ad hoc requests
- Review and interpret agency feedback to support internal response strategy
- Collaborate with internal stakeholders to ensure alignment with regulatory expectations
- Serve as a subject matter expert for ophthalmology-related regulatory matters
- Maintain open communication with the lead biostatistician (former FDA colleague) and cross-functional team
- Advise on potential statistical implications during regulatory meetings submissions and follow-ups
Requirements:
- PhD in Statistics Biostatistics or related field
- Prior experience as an FDA Statistical Reviewer(required)
- Ophthalmology experiencewith a proven history of supporting successful FDA submissions in this space
- Strong knowledge of regulatory guidance statistical methodologies and clinical trial data interpretation
- Ability to work independently and respond quickly to evolving regulatory needs
Required Experience:
Senior IC
Employment Type
Contract
