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Senior Biostatistics Consultant FDA Statistical Review Support (Part-Time) - Remote

Fairfield, CT

Posted: 09/05/2025 Industry: Biotech/Pharmaceutical Job Number: 5977

Job Description

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
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 Consultant with prior FDA experience to provide ad hoc statistical review support for 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 ophthalmology therapeutic area.

This is a highly specialized role, ideal for a former FDA Statistical Reviewer who 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 experience with 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

Meet Your Recruiter

Terra Parsons
Director, Biometrics Recruitment

Terra is a Senior Recruiter with 19 years of experience in the pharmaceutical industry. She is driven by a passion for comprehensively understanding the needs of both clients and candidates, and adeptly matching them with opportunities that align with their needs and interests. Her specialization lies in biometrics recruitment, with a focus on sourcing top talent in roles such as statisticians, SAS/statistical programmers, and data managers. Her track record speaks volume about her ability to deliver high-quality candidates and exceed client expectations. In her free time, she enjoys spending time with her family, traveling, and fitness. 

 
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